The following data is part of a premarket notification filed by Headstar Medical Products Co., Ltd with the FDA for Headstar Medical Small Volume Jet Nebulizer.
| Device ID | K121770 |
| 510k Number | K121770 |
| Device Name: | HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | HEADSTAR MEDICAL PRODUCTS CO., LTD 9 F., NO. 8, SEC. 1, CHUNG-SHAN ROAD, HSIN-CHANG City, Taipei County, TW 242 |
| Contact | Gloria Chen |
| Correspondent | Gloria Chen HEADSTAR MEDICAL PRODUCTS CO., LTD 9 F., NO. 8, SEC. 1, CHUNG-SHAN ROAD, HSIN-CHANG City, Taipei County, TW 242 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-15 |
| Decision Date | 2013-04-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711402234226 | K121770 | 000 |
| 04711402234219 | K121770 | 000 |
| 17540195035154 | K121770 | 000 |