K864430Substantially Equivalent

Ma-2 and Ma2+2 Volume Ventilators

Name: K864430 Ma-2 and Ma2+2 Volume Ventilators
Creator: Puritan Bennett Corp.
Published: 1987-01-15
License: https://open.fda.gov/license/

Medtronic, Inc., Overland Park KS / Traditional, Substantially Equivalent

FDA source

K864430 is the FDA 510(k) clearance record for MA-2 AND MA2+2 VOLUME VENTILATORS, cleared for Puritan Bennett Corp. on 1987-01-15. FDA records list 1,525 510(k) clearances for Medtronic, Inc., from 1976-08-23 to 2026-08-13. As of 2026-09-10, FDA records show no recalls naming K864430.

Clearance record

Decision date: 1987-01-15
Received: 1986-11-12 (64 days to decision)
Review panel: Unknown
Applicant: Puritan Bennett Corp. 9401 Indian Creek Pkwy., Overland Park KS
Third party review: No