FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
K Number: K122932
·
Decision Dec 23, 2013
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
108
Applicant Total
1
Review Days
455
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Basic Information
- Device Name
- SPIRO SPEAKING VALVE WITH OXYGEN PORT SPIRO SPEAKING VALVE WITHOUT OXYGEN PORT
- K Number
- K122932
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5800
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fogless International AB
- Date Received
- September 24, 2012
- Decision Date
- December 23, 2013
- Product Code
- JOH
- 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 |
|---|---|---|---|
| JOH | Tube Tracheostomy And Tube Cuff | FDA class 2 | Anesthesiology |
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