The following data is part of a premarket notification filed by Medisize Bv with the FDA for Medisize Gold Heater And Booster T-piece.
| Device ID | K122885 |
| 510k Number | K122885 |
| Device Name: | MEDISIZE GOLD HEATER AND BOOSTER T-PIECE |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MEDISIZE BV Prinsessegracht 20 The Hague, NL 2514 Ap |
| Contact | Iffat Noor |
| Correspondent | Iffat Noor MEDISIZE BV Prinsessegracht 20 The Hague, NL 2514 Ap |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-20 |
| Decision Date | 2013-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788792352 | K122885 | 000 |
| 05055788783145 | K122885 | 000 |
| 05055788790242 | K122885 | 000 |
| 05055788790259 | K122885 | 000 |
| 05055788792277 | K122885 | 000 |
| 05055788792314 | K122885 | 000 |
| 05055788792321 | K122885 | 000 |
| 05055788792338 | K122885 | 000 |
| 05055788792345 | K122885 | 000 |
| 05055788778554 | K122885 | 000 |