The following data is part of a premarket notification filed by Koo(shanghai)industries Co., Ltd. with the FDA for Koo Small Volume Nebulizer (svn).
| Device ID | K112041 |
| 510k Number | K112041 |
| Device Name: | KOO SMALL VOLUME NEBULIZER (SVN) |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | KOO(SHANGHAI)INDUSTRIES CO., LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden KOO(SHANGHAI)INDUSTRIES CO., LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-18 |
| Decision Date | 2011-12-22 |
| Summary: | summary |