The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Spirotel, Model 29-1020.
| Device ID | K031643 |
| 510k Number | K031643 |
| Device Name: | SPIROTEL, MODEL 29-1020 |
| 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 | 2003-05-27 |
| Decision Date | 2003-12-09 |