The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Iqsense Flow Sensor Mouthpiece.
| Device ID | K150515 |
| 510k Number | K150515 |
| Device Name: | IQSense Flow Sensor Mouthpiece |
| Classification | Spirometer, Diagnostic |
| Applicant | SDI DIAGNOSTICS, INC. 10 HAMPDEN DRIVE Easton, MA 02375 |
| Contact | Cosimo Cariolo |
| Correspondent | Cosimo Cariolo SDI DIAGNOSTICS, INC. 10 HAMPDEN DRIVE 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 | 2015-03-02 |
| Decision Date | 2016-01-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B279S298050300 | K150515 | 000 |
| B279S298050025 | K150515 | 000 |
| B279DP410100 | K150515 | 000 |
| B279DP400300 | K150515 | 000 |
| B279DP400100 | K150515 | 000 |
| B279298050K100 | K150515 | 000 |