The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor Model N-2500 Anesthesia Safety Monitor.
| Device ID | K896629 |
| 510k Number | K896629 |
| Device Name: | NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR |
| Classification | Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Applicant | NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Contact | Virginia Perry |
| Correspondent | Virginia Perry NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Product Code | CBS |
| CFR Regulation Number | 868.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-22 |
| Decision Date | 1990-02-12 |