FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
K Number: K142764
·
Decision Jul 9, 2015
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
102
Applicant Total
1
Review Days
287
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Basic Information
- Device Name
- KYOLING CPR Mask with Oxygen Port and Without Oxygen Port
- K Number
- K142764
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5870
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hangzhou Jinlin Medical Appliances Co., Ltd.
- Date Received
- September 25, 2014
- Decision Date
- July 9, 2015
- 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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