K828565Substantially Equivalent

Brattle R-Detect Physiological Synchronizers

Name: K828565 Brattle R-Detect Physiological Synchronizers
Creator: Medical Electronics Corp.
Published: 1983-01-03
License: https://open.fda.gov/license/

Medical Electronics Corp., Cambridge MA / Traditional, Substantially Equivalent

FDA source

K828565 is the FDA 510(k) clearance record for BRATTLE R-DETECT PHYSIOLOGICAL SYNCHRONIZERS, cleared for Medical Electronics Corp. on 1983-01-03. FDA records list 2 510(k) clearances for Medical Electronics Corp., from 1983-01-03 to 1983-07-07. As of 2026-09-10, FDA records show no recalls naming K828565.

Clearance record

Decision date: 1983-01-03
Received: 1982-10-20 (75 days to decision)
Review panel: Unknown
Applicant: Medical Electronics Corp. 320 Charles St., Cambridge MA
Third party review: No