K781215Substantially Equivalent

Test Module Model Dm-352

Name: K781215 Test Module Model Dm-352
Creator: Extracorporeal Medical Specialities, Inc.
Published: 1978-08-31
License: https://open.fda.gov/license/

Extracorporeal Medical Specialities, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K781215 is the FDA 510(k) clearance record for TEST MODULE MODEL DM-352, cleared for Extracorporeal Medical Specialities, Inc. on 1978-08-31. FDA records list 69 510(k) clearances for Extracorporeal Medical Specialities, Inc., from 1976-10-14 to 1984-11-29. As of 2026-09-10, FDA records show no recalls naming K781215.

Clearance record

Decision date: 1978-08-31
Received: 1978-07-17 (45 days to decision)
Review panel: Unknown
Applicant: Extracorporeal Medical Specialities, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No