The following data is part of a premarket notification filed by Vbm Medizintechnik Gmbh with the FDA for Manujet Iii.
| Device ID | K112783 |
| 510k Number | K112783 |
| Device Name: | MANUJET III |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| Applicant | VBM MEDIZINTECHNIK GMBH 1, EINSTEINSTRASSE SULZ AM NECKAR, Baden-wurttemberg, DE 72172 |
| Contact | Anke Blocher |
| Correspondent | Anke Blocher VBM MEDIZINTECHNIK GMBH 1, EINSTEINSTRASSE SULZ AM NECKAR, Baden-wurttemberg, DE 72172 |
| Product Code | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-26 |
| Decision Date | 2011-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04250105615456 | K112783 | 000 |
| 04250105608595 | K112783 | 000 |
| 14250105604280 | K112783 | 000 |