Cleared Traditional

OPHTHASCAN MINI-B

K884595 · Biophysic Medical, Inc. · Radiology
Jan 1989
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K884595 is an FDA 510(k) clearance for the OPHTHASCAN MINI-B, a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO), submitted by Biophysic Medical, Inc. (Pleasant Hill, US). The FDA issued a Cleared decision on January 3, 1989, 61 days after receiving the submission on November 3, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K884595 FDA.gov
FDA Decision Cleared SESE
Date Received November 03, 1988
Decision Date January 03, 1989
Days to Decision 61 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1560

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