FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXHALATION VALVE
K Number: K132143
·
Decision Jun 4, 2014
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
3
Review Days
328
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Basic Information
- Device Name
- EXHALATION VALVE
- K Number
- K132143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intersurgical Incorporated
- Date Received
- July 11, 2013
- Decision Date
- June 4, 2014
- 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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