The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Astra 300.
| Device ID | K061571 |
| 510k Number | K061571 |
| Device Name: | ASTRA 300 |
| 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 | 2006-06-06 |
| Decision Date | 2007-01-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B279S295303 | K061571 | 000 |
| B279S295200050 | K061571 | 000 |
| B279S295200 | K061571 | 000 |
| B279S295102050 | K061571 | 000 |
| B279S295102 | K061571 | 000 |
| B279S295101050 | K061571 | 000 |
| B279S295101 | K061571 | 000 |
| B279S295100050 | K061571 | 000 |
| B279S295100 | K061571 | 000 |
| B279295405SPO1 | K061571 | 000 |
| B279S295201 | K061571 | 000 |
| B279S295201050 | K061571 | 000 |
| B279S295302050 | K061571 | 000 |
| B279S295302 | K061571 | 000 |
| B279S295301050 | K061571 | 000 |
| B279S295301 | K061571 | 000 |
| B279S295300050 | K061571 | 000 |
| B279S295300 | K061571 | 000 |
| B279S295203050 | K061571 | 000 |
| B279S295202050 | K061571 | 000 |
| B279S295202 | K061571 | 000 |
| B279295405SPO050 | K061571 | 000 |
| B279295405S1 | K061571 | 000 |
| B279295405S050 | K061571 | 000 |
| B279295300D1 | K061571 | 000 |
| B279295202S1 | K061571 | 000 |
| B279295202S050 | K061571 | 000 |
| B279295201P050 | K061571 | 000 |
| B279295102S1 | K061571 | 000 |
| B279295102S050 | K061571 | 000 |
| B279295100S1 | K061571 | 000 |
| B279295100L1 | K061571 | 000 |
| B279295100D1 | K061571 | 000 |
| B279295300P1 | K061571 | 000 |
| B279295300R1 | K061571 | 000 |
| B279295405PO1 | K061571 | 000 |
| B279295405PO050 | K061571 | 000 |
| B279295403S1 | K061571 | 000 |
| B279295403S050 | K061571 | 000 |
| B279295400D1 | K061571 | 000 |
| B279295302S1 | K061571 | 000 |
| B279295302S050 | K061571 | 000 |
| B279295302BT1 | K061571 | 000 |
| B279295301P050 | K061571 | 000 |
| B279SIB401 | K061571 | 000 |
| B79295200D1 | K061571 | 000 |
| B279SIB401050 | K061571 | 000 |
| B279SIB400050 | K061571 | 000 |
| B279SIB400 | K061571 | 000 |
| B279SIB302S1 | K061571 | 000 |
| B279SIB302050 | K061571 | 000 |
| B279SIB302 | K061571 | 000 |
| B279SIB301050 | K061571 | 000 |
| B279SIB301 | K061571 | 000 |
| B279SIB300R1 | K061571 | 000 |
| B279SIB403 | K061571 | 000 |
| B279SIB403S050 | K061571 | 000 |
| B279SIB405SPO1 | K061571 | 000 |
| B279SIB405SPO050 | K061571 | 000 |
| B279SIB405S1 | K061571 | 000 |
| B279SIB405S050 | K061571 | 000 |
| B279SIB405PO1 | K061571 | 000 |
| B279SIB405PO050 | K061571 | 000 |
| B279SIB405050 | K061571 | 000 |
| B279SIB405 | K061571 | 000 |
| B279SIB403S1 | K061571 | 000 |
| B279SIB300D1 | K061571 | 000 |
| B279SIB300 | K061571 | 000 |
| B279SIB202S1 | K061571 | 000 |
| B279SIB100D1 | K061571 | 000 |
| B279SIB100 | K061571 | 000 |
| B279S295405050 | K061571 | 000 |
| B279S295405 | K061571 | 000 |
| B279S295403050 | K061571 | 000 |
| B279S295403 | K061571 | 000 |
| B279S295401050 | K061571 | 000 |
| B279S295401 | K061571 | 000 |
| B279S295400050 | K061571 | 000 |
| B279SIB100S1 | K061571 | 000 |
| B279SIB101 | K061571 | 000 |
| B279SIB202S050 | K061571 | 000 |
| B279SIB202050 | K061571 | 000 |
| B279SIB202 | K061571 | 000 |
| B279SIB201050 | K061571 | 000 |
| B279SIB201 | K061571 | 000 |
| B279SIB200D1 | K061571 | 000 |
| B279SIB200 | K061571 | 000 |
| B279SIB102 | K061571 | 000 |
| B279SIB101050 | K061571 | 000 |
| B279S295400 | K061571 | 000 |