Cleared Traditional

K884917 - RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM

K884917 is an FDA 510(k) clearance for RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM, manufactured by Amg Medical Equipments, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K884917 · Amg Medical Equipments, Inc. · Radiology device
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Mar 1989
Decision
101d
Days
Class 2
Risk

K884917 is an FDA 510(k) clearance for the RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Amg Medical Equipments, Inc. (Elk Grove, US). The FDA issued a Cleared decision on March 9, 1989 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Amg Medical Equipments, Inc. devices

FDA 510(k) Submission Details - K884917

510(k) Number K884917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1988
Decision Date March 09, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 107d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
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 Radiology devices follow this clearance model.

Regulatory Peers - IZH System, X-ray, Mammographic

All 113
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K884917.
STEREOTACTIC BIOPSY ATTACHMENT
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MAM-2 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884676 · Elscint, Inc. · Jan 1989
MAM LS-3 MICROFOCUS MAMMOGRAPHY SYSTEM W/MAGNIFI.
K884677 · Elscint, Inc. · Jan 1989