The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor Symphony Pulse Oximeter Model N-3000.
| Device ID | K942347 |
| 510k Number | K942347 |
| Device Name: | NELLCOR SYMPHONY PULSE OXIMETER MODEL N-3000 |
| Classification | Oximeter |
| Applicant | NELLCOR, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 |
| Contact | David A C. Green |
| Correspondent | David A C. Green NELLCOR, INC. 11150 THOMPSON AVE. Lenexa, KS 66219 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-17 |
| Decision Date | 1995-05-12 |