FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
CPR Face Shield
K Number: K192285
·
Decision Nov 25, 2020
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
1
Review Days
461
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Basic Information
- Device Name
- CPR Face Shield
- K Number
- K192285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Firstar Healthcare Company Limited (Guangzhou)
- Date Received
- August 22, 2019
- Decision Date
- November 25, 2020
- 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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