The following data is part of a premarket notification filed by Southmedic, Inc. with the FDA for Smdia-1000.
| Device ID | K101953 |
| 510k Number | K101953 |
| Device Name: | SMDIA-1000 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | SOUTHMEDIC, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden SOUTHMEDIC, INC. 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 | 2010-07-12 |
| Decision Date | 2011-01-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10620974001697 | K101953 | 000 |
| 10620974001673 | K101953 | 000 |
| 10620974001666 | K101953 | 000 |
| 10620974001635 | K101953 | 000 |
| 10620974001109 | K101953 | 000 |