K854533Substantially Equivalent

Single Channel Brain Stem Response Audiometer Bsr2

Name: K854533 Single Channel Brain Stem Response Audiometer Bsr2
Creator: Madsen Electronics (Canada) , Ltd.
Published: 1986-09-30
License: https://open.fda.gov/license/

Madsen Electronics (Canada), Ltd., Oakville, Ontario, CA / Traditional, Substantially Equivalent

FDA source

K854533 is the FDA 510(k) clearance record for SINGLE CHANNEL BRAIN STEM RESPONSE AUDIOMETER BSR2, cleared for Madsen Electronics (Canada) , Ltd. on 1986-09-30. FDA records list 17 510(k) clearances for Madsen Electronics (Canada) , Ltd., from 1985-02-25 to 1994-07-18. As of 2026-09-10, FDA records show no recalls naming K854533.

Clearance record

Decision date: 1986-09-30
Received: 1985-11-13 (321 days to decision)
Review panel: Unknown
Applicant: Madsen Electronics (Canada) , Ltd. 2370 Speers Rd., Oakville, Ontario, CA
Third party review: No