FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SOYALA FULL FACE MASK
K Number: K061653
·
Decision Nov 9, 2006
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
449
Applicant Total
9
Review Days
149
Basic Information
- Device Name
- SOYALA FULL FACE MASK
- K Number
- K061653
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
- Date Received
- June 13, 2006
- Decision Date
- November 9, 2006
- Product Code
- BZD
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
| K Number | Device Name | ||
|---|---|---|---|
| K112167 | SOYALA SILKGEL FULL FACE MASK | Nov 16, 2011 | Substantially Equivalent |
| K110884 | EASYFIT SILKGEL NASAL MASK | Jul 12, 2011 | Substantially Equivalent |
| K102515 | NP15 | Mar 11, 2011 | Substantially Equivalent |
| K081014 | SOYALA GEL VENTED | May 9, 2008 | Substantially Equivalent |
| K073673 | SOYALA FULL FACE MASK GEL VENTED | Mar 28, 2008 | Substantially Equivalent |
| K072009 | WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340 | Dec 14, 2007 | Substantially Equivalent |
| K071163 | WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603 | Jul 18, 2007 | Substantially Equivalent |
| K060405 | SOYALA, SOYALA BLUE | Jun 21, 2006 | Substantially Equivalent |