The following data is part of a premarket notification filed by Teleflex Medical, Inc with the FDA for Neonatal Conchasmart Breathing Circuits.
| Device ID | K173280 |
| 510k Number | K173280 |
| Device Name: | Neonatal ConchaSmart Breathing Circuits |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | Teleflex Medical, Inc 3015 Carrington Mill Blvd-6N Morrisville, NC 27560 |
| Contact | Brian Gall |
| Correspondent | Brian Gall Teleflex Medical, Inc 3015 Carrington Mill Blvd-6N Morrisville, NC 27560 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-16 |
| Decision Date | 2018-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704611175 | K173280 | 000 |
| 24026704611168 | K173280 | 000 |
| 24026704611151 | K173280 | 000 |
| 24026704611144 | K173280 | 000 |