Cleared Traditional

OPHTHASCAN 'S' MINI-A

K893035 · Biophysic Medical, Inc. · Radiology
Jun 1989
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K893035 is an FDA 510(k) clearance for the OPHTHASCAN 'S' MINI-A, 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 June 12, 1989, 49 days after receiving the submission on April 24, 1989. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number K893035 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1989
Decision Date June 12, 1989
Days to Decision 49 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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