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510(k) K896615

CINE CAMERA CONTROL MODEL PK2037 by Perkins Mfg. Co. — Product Code IZJ

K896615 is an FDA 510(k) premarket notification submitted by Perkins Mfg. Co. for the device "CINE CAMERA CONTROL MODEL PK2037". The FDA issued a decision of Substantially Equivalent on January 4, 1990. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Perkins Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
November 21, 1989
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 by Perkins Mfg. Co.

  • K972136 — TV MONITOR (P12/17) (June 26, 1997)
  • K954222 — VIDEO ENHANCEMENT UNIT (December 8, 1995)
  • K926348 — SC1000 SCAN CONVERTER (November 19, 1993)
  • K920550 — DISPLAY PROCESSOR - MODEL IDP5100 (April 13, 1992)
  • K915232 — GRUNDIG ELECTRONICS VARIOUS MODELS (January 9, 1992)
  • K910384 — VIDEO ANNOTATOR MODEL PK2310 (April 16, 1991)
  • K904986 — PROGRAMMABLE VIDEO CONTROLLER MODEL PK2060 (December 4, 1990)
  • K904540 — VIDEO SYSTEM INTERFACE MODELS (October 26, 1990)
  • K895500 — PATIENT POSITIONING ACCESSORIES (November 6, 1989)
  • K893644 — PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER (August 9, 1989)

Other clearances for product code IZJ

  • K024085 — CCD CAMERA, MODEL PKP-06000-000 (March 11, 2003)
  • K972130 — DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSAB (October 9, 1997)
  • K945580 — DSP OPTION (January 30, 1995)
  • K920793 — PHILIPS DSI SYSTEM RELEASE 3.2 (July 17, 1992)
  • 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