The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Comfort Flo Humidification System And Nasal Cannula.
| Device ID | K061736 |
| 510k Number | K061736 |
| Device Name: | COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | TELEFLEX MEDICAL 2345 WAUKEGAN ROAD Bannockburn, IL 60015 |
| Contact | Lori Hays |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-06-20 |
| Decision Date | 2006-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704659351 | K061736 | 000 |
| 24026704659344 | K061736 | 000 |
| 24026704596267 | K061736 | 000 |
| 24026704596250 | K061736 | 000 |
| 44026704659355 | K061736 | 000 |
| 44026704659348 | K061736 | 000 |