The following data is part of a premarket notification filed by Nellcor, Inc. with the FDA for Nellcor Stat-cap Airway Co2 Indicator, Model N-60.
| Device ID | K915494 |
| 510k Number | K915494 |
| Device Name: | NELLCOR STAT-CAP AIRWAY CO2 INDICATOR, MODEL N-60 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Contact | Kenneth R Michael |
| Correspondent | Kenneth R Michael NELLCOR, INC. 25495 WHITESELL ST. Hayward, CA 94545 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1993-08-06 |