The following data is part of a premarket notification filed by Hsiner Co., Ltd. with the FDA for Hsiner Resuscitator.
| Device ID | K053466 |
| 510k Number | K053466 |
| Device Name: | HSINER RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| 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 | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-13 |
| Decision Date | 2006-03-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815277025430 | K053466 | 000 |
| 10889483039038 | K053466 | 000 |
| 00817617024349 | K053466 | 000 |
| 00817617024356 | K053466 | 000 |
| 00817617024363 | K053466 | 000 |
| 00817617024370 | K053466 | 000 |
| 00817617024387 | K053466 | 000 |
| 00815277025355 | K053466 | 000 |
| 00815277025379 | K053466 | 000 |
| 00815277025393 | K053466 | 000 |
| 00815277025416 | K053466 | 000 |
| 10889483039021 | K053466 | 000 |