The following data is part of a premarket notification filed by Teleflex Medical with the FDA for Choncha Therm Neptune Heated Humifier, Choncha Therm Neptune Heated Humifier (remanufacturer), Model# 425-00,425-00r.
| Device ID | K063758 |
| 510k Number | K063758 |
| Device Name: | CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | TELEFLEX MEDICAL 2345 WAUKEGAN ROAD Bannockburn, IL 60015 |
| Contact | Lori Hays |
| Correspondent | Lori Hays TELEFLEX MEDICAL 2345 WAUKEGAN ROAD Bannockburn, IL 60015 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-19 |
| Decision Date | 2007-04-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704659689 | K063758 | 000 |
| 14026704396334 | K063758 | 000 |
| 14026704659675 | K063758 | 000 |
| 34026704659631 | K063758 | 000 |
| 34026704659556 | K063758 | 000 |
| 34026704734055 | K063758 | 000 |
| 34026704734086 | K063758 | 000 |
| 34026704734079 | K063758 | 000 |
| 34026704734062 | K063758 | 000 |
| 14026704597762 | K063758 | 000 |
| 30801902124648 | K063758 | 000 |
| 24026704659672 | K063758 | 000 |
| 24026704659665 | K063758 | 000 |
| 24026704659658 | K063758 | 000 |
| 24026704659641 | K063758 | 000 |
| 24026704659634 | K063758 | 000 |
| 24026704659559 | K063758 | 000 |
| 30801902124662 | K063758 | 000 |
| 30801902124655 | K063758 | 000 |
| 34026704734024 | K063758 | 000 |