K791399Substantially Equivalent

Acu-Alert

Name: K791399 Acu-Alert
Creator: Acumed Instruments Corp.
Published: 1979-10-11
License: https://open.fda.gov/license/

Acumed Instruments Corp., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K791399 is the FDA 510(k) clearance record for ACU-ALERT, cleared for Acumed Instruments Corp. on 1979-10-11. FDA records list 8 510(k) clearances for Acumed Instruments Corp., from 1979-06-27 to 1986-10-02. As of 2026-09-10, FDA records show no recalls naming K791399.

Clearance record

Decision date: 1979-10-11
Received: 1979-07-16 (87 days to decision)
Review panel: Unknown
Applicant: Acumed Instruments Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No