FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IMPROVED MOUTHPIECE
K Number: K840459
·
Decision Feb 17, 1984
Classifications
1
FEI Numbers
162
Registration Numbers
162
Same Product Code
24
Applicant Total
4
Review Days
15
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Basic Information
- Device Name
- IMPROVED MOUTHPIECE
- K Number
- K840459
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5620
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Kinetix
- Date Received
- February 2, 1984
- Decision Date
- February 17, 1984
- Product Code
- BYP
- 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 |
|---|---|---|---|
| BYP | Mouthpiece, Breathing | FDA class 1 | Anesthesiology |
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