The following data is part of a premarket notification filed by Cardinal Health Germany 234 Gmbh with the FDA for Asthma Monitor Model, Am1.
| Device ID | K090486 |
| 510k Number | K090486 |
| Device Name: | ASTHMA MONITOR MODEL, AM1 |
| Classification | Spirometer, Diagnostic |
| Applicant | CARDINAL HEALTH GERMANY 234 GMBH REGULATORY AFFAIRS 1100 BIRD CENTER DRIVE Palm Springs, CA 92262 |
| Contact | Thomas Gutierrez |
| Correspondent | Thomas Gutierrez CARDINAL HEALTH GERMANY 234 GMBH REGULATORY AFFAIRS 1100 BIRD CENTER DRIVE Palm Springs, CA 92262 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-25 |
| Decision Date | 2009-05-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000320 | K090486 | 000 |
| 04057155000177 | K090486 | 000 |
| 04057155000337 | K090486 | 000 |