The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Astrasonic Spirometer, Model 29-8000.
| Device ID | K092813 |
| 510k Number | K092813 |
| Device Name: | ASTRASONIC SPIROMETER, MODEL 29-8000 |
| Classification | Spirometer, Diagnostic |
| Applicant | SDI DIAGNOSTICS, INC. 10 HAMPDEN DR. Easton, MA 02375 |
| Contact | Cosimo Cariolo |
| Correspondent | Cosimo Cariolo 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 | 2009-09-14 |
| Decision Date | 2010-07-16 |
| Summary: | summary |