The following data is part of a premarket notification filed by Teleflex, Inc. with the FDA for Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart Column.
| Device ID | K131912 |
| 510k Number | K131912 |
| Device Name: | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | TELEFLEX, INC. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Amanda Webb |
| Correspondent | Amanda Webb TELEFLEX, INC. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-26 |
| Decision Date | 2014-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704646818 | K131912 | 000 |
| 24026704629071 | K131912 | 000 |
| 24026704629064 | K131912 | 000 |
| 54026704728539 | K131912 | 000 |
| 54026704728522 | K131912 | 000 |
| 54026704728515 | K131912 | 000 |
| 54026704728508 | K131912 | 000 |
| 24026704669640 | K131912 | 000 |