The following data is part of a premarket notification filed by Medisize Bv with the FDA for Medisize Gold.
| Device ID | K052615 |
| 510k Number | K052615 |
| Device Name: | MEDISIZE GOLD |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | MEDISIZE BV EDISONSTRAAT 1 Hillegom, NL 2180 Ab |
| Contact | Sopiha 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 | 2005-09-23 |
| Decision Date | 2005-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788792376 | K052615 | 000 |
| 05055788792307 | K052615 | 000 |
| 05055788792291 | K052615 | 000 |
| 05055788792284 | K052615 | 000 |
| 05055788783121 | K052615 | 000 |
| 05055788778493 | K052615 | 000 |
| 05055788778486 | K052615 | 000 |
| 05055788778479 | K052615 | 000 |
| 05055788776215 | K052615 | 000 |