The following data is part of a premarket notification filed by Respironics Novametrix Llc with the FDA for Loflo C5 Co2 Sensor.
| Device ID | K053174 |
| 510k Number | K053174 |
| Device Name: | LOFLO C5 CO2 SENSOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| 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 | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838084681 | K053174 | 000 |
| 00884838082304 | K053174 | 000 |
| 00884838082298 | K053174 | 000 |
| 00884838082281 | K053174 | 000 |
| 00884838074736 | K053174 | 000 |
| 00884838013681 | K053174 | 000 |