The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor Symphony N-3000 Pulse Oximeter.
| Device ID | K952316 |
| 510k Number | K952316 |
| Device Name: | NELLCOR SYMPHONY N-3000 PULSE OXIMETER |
| Classification | Oximeter |
| Applicant | NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton, CA 94588 |
| Contact | Marsha J Stone |
| Correspondent | Marsha J Stone NELLCOR, INC. 4280 HACIENDA DR. P.O. BOX 8004 Pleasanton, CA 94588 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-17 |
| Decision Date | 1995-08-17 |