The following data is part of a premarket notification filed by Respironics Novametrix, Inc. with the FDA for Modification To Nico With Mars, Model 7300.
| Device ID | K041450 |
| 510k Number | K041450 |
| Device Name: | MODIFICATION TO NICO WITH MARS, MODEL 7300 |
| 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 | 2004-06-01 |
| Decision Date | 2004-06-18 |
| Summary: | summary |