Cleared Traditional

K840832 - SERVOMED OXCARDIORE SPIROGRAPH 324/111

K840832 is an FDA 510(k) clearance for SERVOMED OXCARDIORE SPIROGRAPH 324/111, manufactured by Litton Medical Electronics. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K840832 · Litton Medical Electronics · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1984
Decision
209d
Days
Class 2
Risk

K840832 is an FDA 510(k) clearance for the SERVOMED OXCARDIORE SPIROGRAPH 324/111. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 209 days - an extended review cycle.

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 Litton Medical Electronics devices

FDA 510(k) Submission Details - K840832

510(k) Number K840832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date September 20, 1984
Days to Decision 209 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 125d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 204
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K840832.
DIASCOPE 2
K833689 · S & W Medico Teknik · Oct 1984
SERVOMED BASIC BEDSIDE UNIT SMV 110TP
K840524 · Litton Medical Electronics · Oct 1984
HEART RATE/RESPIRATION SIMULATOR 8310
K841363 · Aequitron Medical, Inc. · Oct 1984
FUKUDA DENSHI FX-302 AUTO/THREE CHAN
K833594 · Brentwood Instruments, Inc. · Sep 1984
HOLTER SCREENING MONITOR HS-221
K842462 · Advantage Medical Systems, Inc. · Sep 1984
LIFESCOPE II
K841499 · Nihon Kohden America, Inc. · Aug 1984