The following data is part of a premarket notification filed by Allied Healthcare Products, Inc. with the FDA for Schuco Mist And Schuco Deluxe Mist.
| Device ID | K051260 |
| 510k Number | K051260 |
| Device Name: | SCHUCO MIST AND SCHUCO DELUXE MIST |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Contact | Wayne Karcher |
| Correspondent | Wayne Karcher ALLIED HEALTHCARE PRODUCTS, INC. 1720 SUBLETTE AVE. St. Louis, MO 63110 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-15 |
| Decision Date | 2005-09-15 |