Soyala, Soyala Blue
by Weinmann Gerate Fur Medizin GmbH + Co. KG
510(k) K060405
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060405 | Date21 Jun 2006 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- BZD
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Soyala, Soyala Blue is a ventilator, non-continuous, also known as a respirator, used in the field of anesthesiology. It is designed to provide ventilation support to patients. The device is classified as a class 2 device.
The Soyala, Soyala Blue is supplied with a product code of BZD and a regulation number of 868.5905. It has been cleared by the FDA with a traditional 510K clearance, and the decision date was 2006-06-21. The device is intended for use in anesthesiology and has a specific registration number associated with it.
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Questions
AI-generated answers, 1 Oct 2026
What is the Soyala Blue ventilator used for?
The Soyala Blue ventilator is used to provide ventilation support to patients in the field of anesthesiology.
What type of device is the Soyala Blue?
The Soyala Blue is a non-continuous ventilator, also known as a respirator, and is classified as a class 2 device.
Is the Soyala Blue ventilator cleared by the FDA?
Yes, the Soyala Blue ventilator has been cleared by the FDA with a traditional 510K clearance, with a decision date of 2006-06-21.