FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
K Number: K150518
·
Decision Jun 29, 2015
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
27
Applicant Total
5
Review Days
119
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Basic Information
- Device Name
- Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm
- K Number
- K150518
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5070
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dupaco, Inc.
- Date Received
- March 2, 2015
- Decision Date
- June 29, 2015
- Product Code
- JXL
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| JXL | Block, Bite | FDA class 2 | Neurology |
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