The following data is part of a premarket notification filed by Hsiner Company with the FDA for Hsiner Cpap Silicone Nasal Mask Size Xs/petite Hsiner Nasal Pillow Mask Hsiner Infant Cpap Cannula.
| Device ID | K120920 |
| 510k Number | K120920 |
| Device Name: | HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | HSINER COMPANY 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks HSINER COMPANY 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 | 2012-03-27 |
| Decision Date | 2012-07-16 |
| Summary: | summary |