FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Manual Resuscitator
K Number: K210288
·
Decision Aug 26, 2021
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
207
Applicant Total
1
Review Days
205
Basic Information
- Device Name
- Disposable Manual Resuscitator
- K Number
- K210288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Xiamen Compower Medical Tech. Co., Ltd.
- Date Received
- February 2, 2021
- Decision Date
- August 26, 2021
- Product Code
- BTM
- 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 |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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