The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for N-395 Pulse Oximeter, Model N-395.
| Device ID | K991823 |
| 510k Number | K991823 |
| Device Name: | N-395 PULSE OXIMETER, MODEL N-395 |
| Classification | Oximeter |
| Applicant | NELLCOR PURITAN BENNETT, INC. 2200 FARADAY AVE. Carlsbad, CA 92008 -7208 |
| Contact | David A. C. Green |
| Correspondent | David A. C. Green NELLCOR PURITAN BENNETT, INC. 2200 FARADAY AVE. Carlsbad, CA 92008 -7208 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-28 |
| Decision Date | 1999-08-25 |
| Summary: | summary |