The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for Nellcor Puritan Bennett Npb-40 Handheld Pulse(npb-40).
| Device ID | K963707 |
| 510k Number | K963707 |
| Device Name: | NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40) |
| Classification | Oximeter |
| Applicant | NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Contact | Donna Page |
| Correspondent | Donna Page NELLCOR PURITAN BENNETT, INC. 4280 HACIENDA DR. Pleasanton, CA 94588 -2719 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1996-12-13 |
| Summary: | summary |