The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Masterscreen Ios.
| Device ID | K101873 |
| 510k Number | K101873 |
| Device Name: | MASTERSCREEN IOS |
| Classification | Spirometer, Diagnostic |
| Applicant | CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204 |
| Contact | Elmar Niedermeyer |
| Correspondent | Elmar Niedermeyer CAREFUSION GERMANY 234 GMBH LEIBNIZSTRASSE 7 Hoechberg, 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 | 2010-07-06 |
| Decision Date | 2011-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892904597 | K101873 | 000 |
| 04250892904580 | K101873 | 000 |