The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Micro I.
| Device ID | K113096 |
| 510k Number | K113096 |
| Device Name: | MICRO I |
| Classification | Spirometer, Diagnostic |
| Applicant | CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria, DE 97204 |
| Contact | Elmar Niedermeyer |
| Correspondent | Elmar Niedermeyer CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, Bavaria, DE 97204 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2012-04-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 54250892905582 | K113096 | 000 |
| 54250892901355 | K113096 | 000 |
| 14250892904433 | K113096 | 000 |
| 14250892904099 | K113096 | 000 |
| 14250892906543 | K113096 | 000 |