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510(k) K827087

P1808 MOBILE C-ARM IMAGE INTENSIFIER by Precise Optics

K827087 is an FDA 510(k) premarket notification submitted by Precise Optics for the device "P1808 MOBILE C-ARM IMAGE INTENSIFIER". The FDA issued a decision of Substantially Equivalent on March 4, 1982. Precise Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1982
Date Received
January 22, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Precise Optics

  • K030061 — PS 3000 DIGATAL PHOTOSPOT SYSTEM (April 7, 2003)
  • K935580 — PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER (March 16, 1994)
  • K932878 — PRECISION INTRA-ORAL SCOPES (January 6, 1994)
  • 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)

FDA data resources