The following data is part of a premarket notification filed by Sdi Diagnostics, Inc. with the FDA for Astraguard Pulmonary Function Filter.
| Device ID | K062913 |
| 510k Number | K062913 |
| Device Name: | ASTRAGUARD PULMONARY FUNCTION FILTER |
| 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 | 2006-09-27 |
| Decision Date | 2007-01-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B279F06070501 | K062913 | 000 |
| B279F0303300 | K062913 | 000 |
| B279F0311200 | K062913 | 000 |
| B279F0311100 | K062913 | 000 |
| B279F0311300 | K062913 | 000 |
| B279F0312050 | K062913 | 000 |
| B279F0312100 | K062913 | 000 |
| B279F0312300 | K062913 | 000 |
| B279F0320050 | K062913 | 000 |
| B279F0320200 | K062913 | 000 |
| B279F0501050 | K062913 | 000 |
| B279F0501100 | K062913 | 000 |
| B279F0501300 | K062913 | 000 |
| B279F0303100 | K062913 | 000 |
| B279F0303200 | K062913 | 000 |
| B279F06071002 | K062913 | 000 |
| B279S29310705001 | K062913 | 000 |
| B279S2931071002 | K062913 | 000 |
| B279F0300050 | K062913 | 000 |
| B279F0300100 | K062913 | 000 |
| B279F0300300 | K062913 | 000 |
| B279F0301200 | K062913 | 000 |
| B279F0301100 | K062913 | 000 |
| B279F0301300 | K062913 | 000 |
| B279F0302200 | K062913 | 000 |
| B279F0302100 | K062913 | 000 |
| B279F0302300 | K062913 | 000 |
| B279F0502050 | K062913 | 000 |
| B279F0502100 | K062913 | 000 |
| B279F0502200 | K062913 | 000 |
| B279S297993300 | K062913 | 000 |
| B279S297994200 | K062913 | 000 |
| B279S297994100 | K062913 | 000 |
| B279S297994300 | K062913 | 000 |
| B279S297995200 | K062913 | 000 |
| B279S297995100 | K062913 | 000 |
| B279S297995300 | K062913 | 000 |
| B279S297996200 | K062913 | 000 |
| B279S297996100 | K062913 | 000 |
| B279S297996300 | K062913 | 000 |
| B279S297997200 | K062913 | 000 |
| B279S297997100 | K062913 | 000 |
| B279S297993100 | K062913 | 000 |
| B279S297993200 | K062913 | 000 |
| B279F0502300 | K062913 | 000 |
| B279S297910050 | K062913 | 000 |
| B279S297910200 | K062913 | 000 |
| B279S297990200 | K062913 | 000 |
| B279S297990100 | K062913 | 000 |
| B279S297990300 | K062913 | 000 |
| B279S297991200 | K062913 | 000 |
| B279S297991100 | K062913 | 000 |
| B279S297991300 | K062913 | 000 |
| B279S297992200 | K062913 | 000 |
| B279S297992100 | K062913 | 000 |
| B279S297992300 | K062913 | 000 |
| B279S297997300 | K062913 | 000 |