The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Asthma Monitor Am3.
| Device ID | K092890 |
| 510k Number | K092890 |
| Device Name: | ASTHMA MONITOR AM3 |
| Classification | Spirometer, Diagnostic |
| Applicant | CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Contact | Elmar Nidermeyer |
| Correspondent | Elmar Nidermeyer CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-21 |
| Decision Date | 2010-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04057155000191 | K092890 | 000 |