The following data is part of a premarket notification filed by Medical Consulting Service, Inc. with the FDA for Atomisor.
| Device ID | K970844 |
| 510k Number | K970844 |
| Device Name: | ATOMISOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | MEDICAL CONSULTING SERVICE, INC. 658 DOUGLAS AVENUE,SUITE 1110 Altamonte Springs, FL 32714 |
| Contact | Cheryl Ward |
| Correspondent | Cheryl Ward MEDICAL CONSULTING SERVICE, INC. 658 DOUGLAS AVENUE,SUITE 1110 Altamonte Springs, FL 32714 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-11-13 |
| Summary: | summary |