K822125Substantially Equivalent

Model 57000 Naso-Conjunctiva Isol. Mask

Name: K822125 Model 57000 Naso-Conjunctiva Isol. Mask
Creator: Welch Allyn, Inc.
Published: 1982-08-27
License: https://open.fda.gov/license/

Welch Allyn Inc, Mchenry IL / Traditional, Substantially Equivalent

FDA source

K822125 is the FDA 510(k) clearance record for MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK, cleared for Welch Allyn, Inc. on 1982-08-27. FDA records list 112 510(k) clearances for Welch Allyn, Inc., from 1977-01-18 to 2025-07-13. As of 2026-09-10, FDA records show no recalls naming K822125.

Clearance record

Decision date: 1982-08-27
Received: 1982-07-19 (39 days to decision)
Review panel: Unknown
Applicant: Welch Allyn, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No