Cleared Traditional

K935518 - MOVING IMAGES(TM)

K935518 is an FDA 510(k) clearance for MOVING IMAGES(TM), manufactured by Epm Information Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K935518 · Epm Information Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
195d
Days
Class 2
Risk

K935518 is an FDA 510(k) clearance for the MOVING IMAGES(TM). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Epm Information Systems, Inc. (Midlothian, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 195 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Epm Information Systems, Inc. devices

FDA 510(k) Submission Details - K935518

510(k) Number K935518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received November 03, 1993
Decision Date May 17, 1994
Days to Decision 195 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 140d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BZQ Monitor, Breathing Frequency

All 107
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K935518.
MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995
MODEL 511 INFANT MONITOR
K942170 · Ge Medical Systems Information Technologies · Jun 1995
MICROTRAPPER/MICRODIGITRAPPER, ADD MODIFICATIONS
K924875 · Synectics-Dantec · Jun 1994
ADDITION OF BUILT-IN OXYMETER TO SLEEPSCAN PROD.
K930790 · Bio-Logic Systems Corp. · Jan 1994
MODEL MEDILOG RAPIDE
K923737 · Oxford Medilog, Inc. · Jan 1994
EDENTEC MODEL 3710 I DIGITAL PRINTER
K921819 · Edentec Corp. · Oct 1993