The following data is part of a premarket notification filed by Medisize Bv with the FDA for Medisize Gold Heater And Booster.
| Device ID | K070714 |
| 510k Number | K070714 |
| Device Name: | MEDISIZE GOLD HEATER AND BOOSTER |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MEDISIZE BV EDISONSTRAAT 1 Hillegom, NL 2181 Ab |
| Contact | Sophia Lam |
| Correspondent | J.a. Van Vugt KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont, PA 18914 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-14 |
| Decision Date | 2007-04-30 |