The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Flosense, Model 29-8010.
| Device ID | K990962 |
| 510k Number | K990962 |
| Device Name: | FLOSENSE, MODEL 29-8010 |
| Classification | Pneumotachometer |
| 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 | JAX |
| CFR Regulation Number | 868.2550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-22 |
| Decision Date | 2000-01-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B279S298021 | K990962 | 000 |
| B279DP2010 | K990962 | 000 |
| B279DP2002 | K990962 | 000 |
| B279DP2000 | K990962 | 000 |
| B279298021K1 | K990962 | 000 |
| B279298021F1 | K990962 | 000 |
| B279298020K1 | K990962 | 000 |
| B279298020F1 | K990962 | 000 |
| B279298012K1 | K990962 | 000 |
| B279298012F1 | K990962 | 000 |
| B279298011K | K990962 | 000 |
| B279DP2012 | K990962 | 000 |
| DP2110 | K990962 | 000 |
| B279S298020 | K990962 | 000 |
| B279S298012 | K990962 | 000 |
| B279S298011 | K990962 | 000 |
| B279DP2527 | K990962 | 000 |
| B279DP2524 | K990962 | 000 |
| B279DP2517 | K990962 | 000 |
| B279DP2514 | K990962 | 000 |
| B279DP2507 | K990962 | 000 |
| B279DP2504 | K990962 | 000 |
| B279DP2112 | K990962 | 000 |
| B279298011F | K990962 | 000 |