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510(k) K792225

P1806 MOBILE C-ARM IMAGE INTENSIFIER by Precise Optics — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1979
Date Received
November 5, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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  • K914084 — ENDOSCOPES (January 22, 1992)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (November 27, 1991)
  • K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE (July 26, 1991)
  • K903459 — PRECISION OPTICS ENDOSCOPE ADAPTER (October 26, 1990)
  • K903458 — PRECISION OPTICS IMAGE COUPLER (October 19, 1990)
  • K903457 — PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) (October 19, 1990)
  • K820178 — PI808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)

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