The following data is part of a premarket notification filed by Hsiner Co., Ltd. with the FDA for Cpap/vpap Masks, Models 1225, 1205 And 1235.
| Device ID | K063268 |
| 510k Number | K063268 |
| Device Name: | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HSINER CO., LTD. 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks HSINER CO., LTD. 29201 VIA NORTE Temecula, CA 92591 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-30 |
| Decision Date | 2007-02-23 |
| Summary: | summary |