The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Flosense Ii, Model 29-8040.
| Device ID | K033939 |
| 510k Number | K033939 |
| Device Name: | FLOSENSE II, MODEL 29-8040 |
| Classification | Spirometer, Diagnostic |
| Applicant | SDI DIAGNOSTICS, INC. 10 HAMPDEN DR. Easton, MA 02375 |
| Contact | Michael J Boyle |
| Correspondent | Michael J Boyle SDI DIAGNOSTICS, INC. 10 HAMPDEN DR. Easton, MA 02375 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-15 |
| Decision Date | 2004-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B279S298040250 | K033939 | 000 |
| B279298040F100 | K033939 | 000 |
| B279298040F250 | K033939 | 000 |
| B279298040200 | K033939 | 000 |
| B279298040K100 | K033939 | 000 |
| B279298040K250 | K033939 | 000 |
| B279DP300200 | K033939 | 000 |
| B279DP300100 | K033939 | 000 |
| B279DP300250 | K033939 | 000 |
| DP301200 | K033939 | 000 |
| B279DP301100 | K033939 | 000 |
| B279DP301250 | K033939 | 000 |
| B279DP311200 | K033939 | 000 |
| B279DP311100 | K033939 | 000 |
| B279DP311250 | K033939 | 000 |
| B279S298040200 | K033939 | 000 |
| B279S298040100 | K033939 | 000 |
| B279298040F050 | K033939 | 000 |