Bluepoint Medical GmbH & Co. KG is one of 385 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Bluepoint Medical GmbH & Co. KG - FDA 510(k) Cleared Devices
Recent clearances: Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric, Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.)
2
Total
2
Cleared
0
Denied
Bluepoint Medical GmbH & Co. KG has 2 FDA 510(k) cleared medical devices. Based in Selmsdorf, DE.
Historical record: 2 cleared submissions from 2017 to 2019. Primary specialty: Anesthesiology.
Browse the FDA 510(k) cleared devices submitted by Bluepoint Medical GmbH & Co. KG Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Imagenix, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Bluepoint Medical GmbH & Co. KG
2 devices