510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K972130Substantially Equivalent

Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):x-Ray Covr

Fairmontmedical, Bayswater, Victoria, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972130 is the FDA 510(k) clearance record for DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR, a class II device, cleared for Fairmontmedical on under FDA product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot). FDA records list one 510(k) clearance for Fairmontmedical. As of , FDA records show no recalls naming K972130.

Clearance record

Decision date
Received
(125 days to decision)
Product code
IZJ Camera, X-Ray, Fluorographic, Cine Or Spot
Regulation
21 CFR 892.1620
Device class
Class II
Review panel
Radiology
Applicant
Fairmontmedical 4/21 Malvern St., Bayswater, Victoria, AU
510(k) summary
Summary
Third party review
No

Clearances, product code IZJ

Trailing 12 months

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

FDA records show no clearances under product code IZJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IZJ, 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