Home / 510(k) Clearances / K914184

510(k) K914184

P2020-8-0 BEAM-LIMITING DEVICE by Precise Optics — Product Code KPW

K914184 is an FDA 510(k) premarket notification submitted by Precise Optics for the device "P2020-8-0 BEAM-LIMITING DEVICE". The FDA issued a decision of Substantially Equivalent on November 27, 1991. The device falls under product code KPW (Device, Beam Limiting, X-Ray, Diagnostic), a Class II device regulated under 21 CFR 892.1610. Precise Optics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1991
Date Received
September 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Beam Limiting, X-Ray, Diagnostic
Device Class
Class II
Regulation Number
892.1610
Review Panel
RA
Submission Type

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)
  • 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)
  • K827087 — P1808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)
  • K820178 — PI808 MOBILE C-ARM IMAGE INTENSIFIER (March 4, 1982)

Other clearances for product code KPW

  • K093596 — LUMOS, MODEL R 72B (January 12, 2010)
  • K062788 — COLLIMATOR, MODEL M-38 (December 28, 2006)
  • K030487 — R 72 (August 1, 2003)
  • K954310 — BLA-800A (October 18, 1995)
  • K946320 — R 302 (May 11, 1995)
  • K904587 — DENSICOMP 250 (January 24, 1991)
  • K904044 — TF-63SA (November 29, 1990)
  • K904489 — EUREKA EXTENSION CYLINDERS (October 15, 1990)
  • K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (March 5, 1982)
  • K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (March 4, 1982)

FDA data resources