The following data is part of a premarket notification filed by Gottlieb Weinmann Geraete Fuer Medizin Und Arbeits with the FDA for Weinmann Somnomask.
| Device ID | K013738 |
| 510k Number | K013738 |
| Device Name: | WEINMANN SOMNOMASK |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS KRONSAALSWEG 40 Hamburg, DE 22525 |
| Contact | Eckhardt Albers |
| Correspondent | Eckhardt Albers GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS KRONSAALSWEG 40 Hamburg, DE 22525 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-13 |
| Decision Date | 2002-01-22 |
| Summary: | summary |