The following data is part of a premarket notification filed by Respironics Novametrix Llc with the FDA for Mercury Vco2 Module With Capnostat 5.
| Device ID | K080652 |
| 510k Number | K080652 |
| Device Name: | MERCURY VCO2 MODULE WITH CAPNOSTAT 5 |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | RESPIRONICS NOVAMETRIX LLC 5 TECHNOLOGY DRIVE Wallingford, CT 06492 |
| Contact | Kevin Mader |
| Correspondent | Kevin Mader RESPIRONICS NOVAMETRIX LLC 5 TECHNOLOGY DRIVE Wallingford, CT 06492 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-07 |
| Decision Date | 2008-06-20 |
| Summary: | summary |