The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Npb-190 Pulse Oximeter (npb-190).
| Device ID | K971946 |
| 510k Number | K971946 |
| Device Name: | NPB-190 PULSE OXIMETER (NPB-190) |
| Classification | Oximeter |
| Applicant | NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Contact | Roger D Brown |
| Correspondent | Roger D Brown NELLCOR PURITAN BENNETT, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 -2301 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-08-25 |
| Summary: | summary |