The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Powerbase Ii (pb2).
| Device ID | K901399 |
| 510k Number | K901399 |
| Device Name: | POWERBASE II (PB2) |
| Classification | Oximeter |
| Applicant | NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Contact | R Michael |
| Correspondent | R Michael NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-26 |
| Decision Date | 1990-06-12 |