The following data is part of a premarket notification filed by Carefusion Germany 234 Gmbh with the FDA for Microblab, Microloop.
| Device ID | K141936 |
| 510k Number | K141936 |
| Device Name: | MICROBLAB, MICROLOOP |
| 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 | 2014-07-17 |
| Decision Date | 2014-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250892980249 | K141936 | 000 |
| 34250892980233 | K141936 | 000 |
| 34250892904185 | K141936 | 000 |
| 34250892904178 | K141936 | 000 |
| 34250892904161 | K141936 | 000 |
| 34250892901627 | K141936 | 000 |
| 34250892901610 | K141936 | 000 |
| 34250892901603 | K141936 | 000 |
| 14250892904334 | K141936 | 000 |
| 14250892904075 | K141936 | 000 |
| 14250892904068 | K141936 | 000 |
| 14250892903856 | K141936 | 000 |
| 14250892903849 | K141936 | 000 |
| 14250892905751 | K141936 | 000 |
| 14250892906703 | K141936 | 000 |
| 14250892906697 | K141936 | 000 |
| 14250892906680 | K141936 | 000 |
| 14250892906574 | K141936 | 000 |
| 34250892980257 | K141936 | 000 |
| 34250892980264 | K141936 | 000 |
| 04250892904153 | K141936 | 000 |
| 04250892901633 | K141936 | 000 |
| 54250892905575 | K141936 | 000 |
| 54250892905568 | K141936 | 000 |
| 54250892905551 | K141936 | 000 |
| 54250892905483 | K141936 | 000 |
| 54250892905476 | K141936 | 000 |
| 54250892905469 | K141936 | 000 |
| 54250892904202 | K141936 | 000 |
| 54250892904196 | K141936 | 000 |
| 54250892902994 | K141936 | 000 |
| 54250892901515 | K141936 | 000 |
| 54250892901508 | K141936 | 000 |
| 54250892901461 | K141936 | 000 |
| 54250892901423 | K141936 | 000 |
| 54250892901393 | K141936 | 000 |
| 54250892901386 | K141936 | 000 |
| 14250892906567 | K141936 | 000 |