K837029Substantially Equivalent

Echosine 1000, Pulsed a-Mode Ultrasound Device

Name: K837029 Echosine 1000, Pulsed a-Mode Ultrasound Device
Creator: American Electromedics Corp.
Published: 1983-03-22
License: https://open.fda.gov/license/

American Electromedics Corp., Hudson NH / Traditional, Substantially Equivalent

FDA source

K837029 is the FDA 510(k) clearance record for ECHOSINE 1000, PULSED A-MODE ULTRASOUND DEVICE, cleared for American Electromedics Corp. on 1983-03-22. FDA records list 20 510(k) clearances for American Electromedics Corp., from 1982-09-30 to 1998-11-18. As of 2026-09-10, FDA records show no recalls naming K837029.

Clearance record

Decision date: 1983-03-22
Received: 1982-12-10 (102 days to decision)
Review panel: Unknown
Applicant: American Electromedics Corp. 13 Sagamore Park Rd., Hudson NH
Third party review: No