510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K884917Substantially Equivalent

Resuscitator's Guard Suction Control System

Amg Medical Equipments, Inc., Elk Grove IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884917 is the FDA 510(k) clearance record for RESUSCITATOR'S GUARD SUCTION CONTROL SYSTEM, a class II device, cleared for Amg Medical Equipments, Inc. on under FDA product code IZH (System, X-Ray, Mammographic). FDA records list 2 510(k) clearances for Amg Medical Equipments, Inc., from to . As of , FDA records show no recalls naming K884917.

Clearance record

Decision date
Received
(101 days to decision)
Product code
IZH System, X-Ray, Mammographic
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Amg Medical Equipments, Inc. 743 Michigan Ln., Elk Grove IL
Third party review
No

Clearances, product code IZH

Trailing 12 months

FDA records hold no clearances under product code IZH in the trailing twelve months.

FDA records show no clearances under product code IZH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260