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

FDA 510(k) K972130 · Fairmontmedical

Substantially Equivalent

510(k) numberK972130

Submission

Device name
Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):X-Ray Covr
Applicant
Fairmontmedical
Bayswater, Victoria, AU
Received
June 6, 1997
Decision date
October 9, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1620
Specialty
Radiology

Other 510(k)s with product code IZJ

510(k)DeviceApplicantDecision
K024085CCD Camera, Model PKP-06000-000IZJ · Traditional Perkins Electronics Co.03/11/2003SE
K945580DSP OptionIZJ · Traditional Philips Medical Systems (Cleveland), Inc.01/30/1995SE
K920793Philips Dsi System Release 3.2IZJ · Traditional Philips Medical Systems, Inc.07/17/1992SE
K896615Cine Camera Control Model PK2037IZJ · Traditional Perkins Mfg. Co.01/04/1990SE
K881688DTV-4114 Fluoroscopic Television CameraIZJ · Traditional Adac Laboratories05/18/1988SE
K853983Canon X-Ray 35MM Cine Camera CSI-35IZJ · Traditional Canon USA, Inc.10/16/1985SE
K812613Vidicam 200IZJ · Traditional Diversified P.A.12/08/1981SE
K810191Sircam 103IZJ · Traditional Siemens Corp.02/26/1981SE
K810072105MM Roll Film Fluorogr. Camera, #105IZJ · Traditional Scientex Corp.02/12/1981SE
K802132105MM Spot Film CameraIZJ · Traditional Instrumentation Camera, Inc.10/23/1980SE

Questions and answers

When was Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):X-Ray Covr cleared by the FDA?

Disposable Camera Cover, Enclosed: Disposable Camera Cover, Perforated: Disposable Microscope Cover (Various):X-Ray Covr (K972130) received a 510(k) decision of Substantially Equivalent on October 9, 1997, 125 days after the submission was received.

What is the product code of K972130?

The FDA product code is IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot, a Class II (moderate risk) device regulated under 21 CFR 892.1620.