FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERA 103
K Number: K897143
·
Decision Apr 27, 1990
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
2
Applicant Total
3
Review Days
121
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Basic Information
- Device Name
- VERA 103
- K Number
- K897143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1050
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Madsen North America, Inc.
- Date Received
- December 27, 1989
- Decision Date
- April 27, 1990
- Product Code
- LYN
- 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 |
|---|---|---|---|
| LYN | Apparatus, Visual Reinforcement Audiometric | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYN), ordered by most recent decision date.
SENSICARE SYNTHETIC, SURGICAL GLOVE LINER
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VISUAL REINFORCE. AUDIO CASSETTE UNIT: BASIC & ADV
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