The following data is part of a premarket notification filed by Nellcor Puritan Bennett, Inc. with the FDA for N-395 Pulse Oximeter, With Extended Device Claims.
| Device ID | K993637 |
| 510k Number | K993637 |
| Device Name: | N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-28 |
| Decision Date | 1999-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30884522000813 | K993637 | 000 |
| 20884522001141 | K993637 | 000 |
| 20884522000908 | K993637 | 000 |
| 20884522000854 | K993637 | 000 |
| 20884522000847 | K993637 | 000 |
| 10884521084100 | K993637 | 000 |
| 20884521084091 | K993637 | 000 |
| 20884521084084 | K993637 | 000 |
| 20884521084077 | K993637 | 000 |