The following data is part of a premarket notification filed by Amsino International, Inc. with the FDA for Amsure Nebulizer.
| Device ID | K070411 |
| 510k Number | K070411 |
| Device Name: | AMSURE NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Contact | Ching C Seah |
| Correspondent | Ching C Seah AMSINO INTERNATIONAL, INC. 855 TOWNE CENTER DR. Pomona, CA 91767 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-12 |
| Decision Date | 2007-10-01 |
| Summary: | summary |