The following data is part of a premarket notification filed by Respironics Novametrix, Inc. with the FDA for Capnostat 5.
| Device ID | K042601 |
| 510k Number | K042601 |
| Device Name: | CAPNOSTAT 5 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | RESPIRONICS NOVAMETRIX, INC. 5 TECHNOLOGY DR. Wallingford, CT 06492 |
| Contact | Kevin Mader |
| Correspondent | Kevin Mader RESPIRONICS NOVAMETRIX, INC. 5 TECHNOLOGY DR. Wallingford, CT 06492 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-24 |
| Decision Date | 2004-11-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838082267 | K042601 | 000 |
| 00884838082250 | K042601 | 000 |
| 00884838013667 | K042601 | 000 |