The following data is part of a premarket notification filed by Weinmann Gerate Fur Medizin Gmbh + Co. Kg with the FDA for Soyala, Soyala Blue.
| Device ID | K060405 |
| 510k Number | K060405 |
| Device Name: | SOYALA, SOYALA BLUE |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG KRONSAALSWEG 40 Hamburg, DE 22525 |
| Contact | Eckhardt Albers |
| Correspondent | Eckhardt Albers WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG 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 | 2006-02-16 |
| Decision Date | 2006-06-21 |