FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LMA FAMILY OF AIRWAYS
K Number: K130304
·
Decision May 30, 2014
Classifications
1
FEI Numbers
229
Registration Numbers
229
Same Product Code
56
Applicant Total
4
Review Days
477
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Basic Information
- Device Name
- LMA FAMILY OF AIRWAYS
- K Number
- K130304
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5110
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- The Laryngeal Mask Co., Ltd.
- Date Received
- February 7, 2013
- Decision Date
- May 30, 2014
- Product Code
- CAE
- 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 |
|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | FDA class 1 | Anesthesiology |
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