Cleared Traditional

K071802 - TESLA GUARD

K071802 is the FDA 510(k) clearance for TESLA GUARD by Mammendorfer Institut Fur Physik Und Medizin GmbH. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K071802 · Mammendorfer Institut Fur Physik Und Medizin GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
130d
Days
Class 2
Risk

K071802 is an FDA 510(k) clearance for the TESLA GUARD, MODEL EFT G04. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Mammendorfer Institut Fur Physik Und Medizin GmbH (Golden, US). The FDA issued a Cleared decision on November 9, 2007 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Mammendorfer Institut Fur Physik Und Medizin GmbH devices

Submission Details

510(k) Number K071802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2007
Decision Date November 09, 2007
Days to Decision 130 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 125d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 124
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K071802.
VITAL SIGNS MONITOR-VSM 6000 SERIES
K101445 · Welch Allyn, Inc. · Jun 2010
INTELLIBRIDGE SYSTEM
K093177 · Philips Medical Systems · Dec 2009
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
K082812 · Omron Healthcare, Inc. · Oct 2008
MODIFICATION TO: UNITY NETWORK ID
K071982 · Ge Medical Systems Information Technologies · Sep 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
K071645 · Omron Healthcare, Inc. · Jul 2007
VS-800 VITAL SIGNS MONITOR
K063055 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2006