The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Microgard Ii.
| Device ID | K111408 |
| 510k Number | K111408 |
| Device Name: | MICROGARD II |
| Classification | Filter, Bacterial, Breathing-circuit |
| 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 | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-19 |
| Decision Date | 2011-10-17 |
| Summary: | summary |