P2020-8-0 BEAM-LIMITING DEVICE— 510(k) K914184

Substantially Equivalent

Precise Optics

FDA 510(k) clearance K914184 for P2020-8-0 BEAM-LIMITING DEVICE, Substantially Equivalent on 1991-11-27. Applicant: Precise Optics. Device class: 2.

Clearance details

Applicant: Precise Optics
Product code: Code KPW
Device class: Class 2
Regulation: 21 CFR 892.1610
Advisory panel: Radiology
Date received: 1991-09-18
Decision date: 1991-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bay Shore, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KPW

K093596 — LUMOS, MODEL R 72B2010-01-12
K062788 — COLLIMATOR, MODEL M-382006-12-28
K030487 — R 722003-08-01
K954310 — BLA-800A1995-10-18
K946320 — R 3021995-05-11

More clearances from Precise Optics

K030061 — PS 3000 DIGATAL PHOTOSPOT SYSTEM2003-04-07
K935580 — PHF20 20 MOBILE C-ARM IMAGE INTENSIFIER1994-03-16
K932878 — PRECISION INTRA-ORAL SCOPES1994-01-06
K914084 — ENDOSCOPES1992-01-22
K911744 — PRECISION OPTICS CORPORATION LAPAROSCOPE1991-07-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.