The following data is part of a premarket notification filed by Headstar Medical Products Co., Ltd with the FDA for Headstar's Manual Emergency Resuscitator.
| Device ID | K002846 |
| 510k Number | K002846 |
| Device Name: | HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | HEADSTAR MEDICAL PRODUCTS CO., LTD NO 23, LANE 431, HWA CHEN RD HSIN-CHUANG CITY Taipei Hsien, CN Roc 242 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-12 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816703021309 | K002846 | 000 |
| 04711402230464 | K002846 | 000 |
| 04711402230471 | K002846 | 000 |
| 04711402230488 | K002846 | 000 |
| 10818566013047 | K002846 | 000 |
| 10818566013054 | K002846 | 000 |
| 10818566013061 | K002846 | 000 |
| 00816703021255 | K002846 | 000 |
| 00816703021262 | K002846 | 000 |
| 00816703021279 | K002846 | 000 |
| 00816703021286 | K002846 | 000 |
| 00816703021293 | K002846 | 000 |
| 04711402230280 | K002846 | 000 |