Cleared Traditional

P2020-8-0 BEAM-LIMITING DEVICE

K914184 · Precise Optics · Radiology
Nov 1991
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K914184 is an FDA 510(k) clearance for the P2020-8-0 BEAM-LIMITING DEVICE, a Device, Beam Limiting, X-ray, Diagnostic (Class II — Special Controls, product code KPW), submitted by Precise Optics (Bay Shore, US). The FDA issued a Cleared decision on November 27, 1991, 70 days after receiving the submission on September 18, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K914184 FDA.gov
FDA Decision Cleared SESE
Date Received September 18, 1991
Decision Date November 27, 1991
Days to Decision 70 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KPW — Device, Beam Limiting, X-ray, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610