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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 Mar 4, 1982. Precise Optics has 12 other 510(k) clearances on record.

Clearance Details

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

Other clearances by Precise Optics

  • K030061 — PS 3000 DIGATAL PHOTOSPOT SYSTEM (Apr 7, 2003)
  • K935580 — PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER (Mar 16, 1994)
  • K932878 — PRECISION INTRA-ORAL SCOPES (Jan 6, 1994)
  • K914084 — ENDOSCOPES (Jan 22, 1992)
  • K914184 — P2020-8-0 BEAM-LIMITING DEVICE (Nov 27, 1991)
  • K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE (Jul 26, 1991)
  • K903459 — PRECISION OPTICS ENDOSCOPE ADAPTER (Oct 26, 1990)
  • K903458 — PRECISION OPTICS IMAGE COUPLER (Oct 19, 1990)
  • K903457 — PRECISION OPTICS IMAGE BEAMSPLITTER (COUPLER) (Oct 19, 1990)
  • K820178 — PI808 MOBILE C-ARM IMAGE INTENSIFIER (Mar 4, 1982)

FDA data resources

Source: FDA 510(k) database entry for K827087. Report a data issue: hello@regdatalab.com.