The following data is part of a premarket notification filed by Respironics Healthscan, Inc. with the FDA for Mister Neb Nebulizer Compressor, With Nebulizer, Model Hs123.
| Device ID | K013027 |
| 510k Number | K013027 |
| Device Name: | MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 |
| Classification | Compressor, Air, Portable |
| Applicant | RESPIRONICS HEALTHSCAN, INC. 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Product Code | BTI |
| CFR Regulation Number | 868.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-09-10 |
| Decision Date | 2001-12-06 |
| Summary: | summary |