K828328Substantially Equivalent

Ultrascan Digital A/system III

Name: K828328 Ultrascan Digital A/system III
Creator: Cooper Lasersonics, Inc.
Published: 1983-03-03
License: https://open.fda.gov/license/

Cooper Lasersonics, Inc., Orangeburg NY / Traditional, Substantially Equivalent

FDA source

K828328 is the FDA 510(k) clearance record for ULTRASCAN DIGITAL A/SYSTEM III, cleared for Cooper Lasersonics, Inc. on 1983-03-03. FDA records list 54 510(k) clearances for Cooper Lasersonics, Inc., from 1982-09-13 to 1988-04-18. As of 2026-09-10, FDA records show no recalls naming K828328.

Clearance record

Decision date: 1983-03-03
Received: 1982-12-15 (78 days to decision)
Review panel: Unknown
Applicant: Cooper Lasersonics, Inc. 40 Ramland Rd., Orangeburg NY
Third party review: No