Makani Science, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Makani Science, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Makani Science™ Respiration Monitoring System
1
Total
1
Cleared
0
Denied
Makani Science, Inc. has 1 FDA 510(k) cleared medical devices. Based in Irvine, US.
Latest FDA clearance: Mar 2025. Active since 2025. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Makani Science, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Speed TO Market, Inc. as regulatory consultant. 1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Makani Science, Inc.
1 devices