Cleared Traditional

K961223 - MULTIPLE PARAMETER TELEMETRY

K961223 · Criticare Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1996
Decision
256d
Days
-
Risk

K961223 is an FDA 510(k) clearance for the MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEMS.

Submitted by Criticare Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on December 10, 1996 after a review of 256 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel. 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 Criticare Systems, Inc. devices

FDA 510(k) Submission Details - K961223

510(k) Number K961223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1996
Decision Date December 10, 1996
Days to Decision 256 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 125d · This submission: 256d
Pathway characteristics
Predicate-based equivalence.

LOS Device Classification - Class ,

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 45
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K961223.
MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT
K974087 · Hewlett-Packard Co. · Jun 1998
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440 · Fukuda Denshi USA, Inc. · Dec 1997
EAGLE 4000 PATIENT MONITOR
K964750 · Marquette Electronics, Inc. · Feb 1997
NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES
K961272 · Nihon Kohden America, Inc. · Nov 1996
QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH
K961014 · Quinton, Inc. · Jul 1996
PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO
K954980 · Hewlett-Packard Co. · May 1996