FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Disposable Endotracheal tube, sterile, AccuCuff
K Number: K160694
·
Decision Apr 7, 2017
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
3
Review Days
389
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Basic Information
- Device Name
- Disposable Endotracheal tube, sterile, AccuCuff
- K Number
- K160694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tianjin Medis Medical Device Co., Ltd.
- Date Received
- March 14, 2016
- Decision Date
- April 7, 2017
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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