510(k) K162014
K162014 is an FDA 510(k) premarket notification submitted by Bluepoint Medical GmbH & Co. KG for the device "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.)". The FDA issued a decision of Substantially Equivalent on Feb 6, 2017. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Bluepoint Medical GmbH & Co. KG has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 6, 2017
- Date Received
- Jul 21, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type
- 510(k)