K837063Substantially Equivalent

Biosound Surgiscan, Ultrasound Imaging System

Name: K837063 Biosound Surgiscan, Ultrasound Imaging System
Creator: Biosound, Inc.
Published: 1983-04-04
License: https://open.fda.gov/license/

Biosound, Inc., Indianapolis IN / Traditional, Substantially Equivalent

FDA source

K837063 is the FDA 510(k) clearance record for BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM, cleared for Biosound, Inc. on 1983-04-04. FDA records list 39 510(k) clearances for Biosound, Inc., from 1983-04-04 to 1997-07-09. As of 2026-09-10, FDA records show no recalls naming K837063.

Clearance record

Decision date: 1983-04-04
Received: 1983-01-17 (77 days to decision)
Review panel: Unknown
Applicant: Biosound, Inc. 6405 Castleway Ct., Indianapolis IN
Third party review: No