The following data is part of a premarket notification filed by Wilfred Kromker Gmbh with the FDA for Ultrasonic Nebuliser Model 2010.
| Device ID | K072136 |
| 510k Number | K072136 |
| Device Name: | ULTRASONIC NEBULISER MODEL 2010 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | WILFRED KROMKER GMBH S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Contact | Stephen Gorski |
| Correspondent | Stephen Gorski WILFRED KROMKER GMBH S65 W35739 PIPER ROAD Eagle, WI 53119 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-02 |
| Decision Date | 2008-07-15 |
| Summary: | summary |