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510(k) K972130

DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR by Fairmontmedical — Product Code IZJ

K972130 is an FDA 510(k) premarket notification submitted by Fairmontmedical for the device "DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR". The FDA issued a decision of Substantially Equivalent on October 9, 1997. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 1997
Date Received
June 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Camera, X-Ray, Fluorographic, Cine Or Spot
Device Class
Class II
Regulation Number
892.1620
Review Panel
RA
Submission Type

Other clearances for product code IZJ

  • K024085 — CCD CAMERA, MODEL PKP-06000-000 (March 11, 2003)
  • K945580 — DSP OPTION (January 30, 1995)
  • K920793 — PHILIPS DSI SYSTEM RELEASE 3.2 (July 17, 1992)
  • K896615 — CINE CAMERA CONTROL MODEL PK2037 (January 4, 1990)
  • K881688 — DTV-4114 FLUOROSCOPIC TELEVISION CAMERA (May 18, 1988)
  • K853983 — CANON X-RAY 35MM CINE CAMERA CSI-35 (October 16, 1985)
  • K812613 — VIDICAM 200 (December 8, 1981)
  • K810191 — SIRCAM 103 (February 26, 1981)
  • K810072 — 105MM ROLL FILM FLUOROGR. CAMERA, #105 (February 12, 1981)
  • K802132 — 105MM SPOT FILM CAMERA (October 23, 1980)

FDA data resources