FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RHINOMETER
K Number: K801938
·
Decision Sep 9, 1980
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
4
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- RHINOMETER
- K Number
- K801938
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Aztec Medical Products, Inc.
- Date Received
- August 12, 1980
- Decision Date
- September 9, 1980
- Product Code
- JYJ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| JYJ | Gauge, Measuring | FDA class 1 | Ear, Nose, Throat |
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