FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇷 Türkiye
Altech® Exhalation Valve (Single Limb and Dual Limb)
K Number: K210992
·
Decision Dec 23, 2021
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
3
Review Days
265
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Basic Information
- Device Name
- Altech® Exhalation Valve (Single Limb and Dual Limb)
- K Number
- K210992
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meditera Tibbi Malzeme San VE Tic AS
- Date Received
- April 2, 2021
- Decision Date
- December 23, 2021
- Product Code
- CBP
- 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 |
|---|---|---|---|
| CBP | Valve, Non-Rebreathing | FDA class 2 | Anesthesiology |
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