The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Comet Capnograph Module.
| Device ID | K941165 |
| 510k Number | K941165 |
| Device Name: | COMET CAPNOGRAPH MODULE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Russ Garrison |
| Correspondent | Russ Garrison SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-11 |
| Decision Date | 1994-10-06 |