The following data is part of a premarket notification filed by Bluepoint Medical Gmbh & Co. Kg with the FDA for 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.).
| Device ID | K162014 |
| 510k Number | K162014 |
| Device Name: | 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.) |
| Classification | Oximeter |
| Applicant | BLUEPOINT MEDICAL GMBH & CO. KG AN DER TRAVE 15 Selmsdorf, DE 23923 |
| Contact | Bernd Lindner |
| Correspondent | Stephen Gorski IMAGENIX, INC. S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-21 |
| Decision Date | 2017-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521617476 | K162014 | 000 |
| 10884521617469 | K162014 | 000 |
| 20884521532318 | K162014 | 000 |
| 10884521532304 | K162014 | 000 |