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510(k) K972136

TV MONITOR (P12/17) by Perkins Mfg. Co. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1997
Date Received
June 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
Review Panel
RA
Submission Type

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  • K904540 — VIDEO SYSTEM INTERFACE MODELS (October 26, 1990)
  • K896615 — CINE CAMERA CONTROL MODEL PK2037 (January 4, 1990)
  • K895500 — PATIENT POSITIONING ACCESSORIES (November 6, 1989)
  • K893644 — PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER (August 9, 1989)

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