FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GSI 38 AUTO TYMP
K Number: K925585
·
Decision Feb 2, 1993
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
69
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- GSI 38 AUTO TYMP
- K Number
- K925585
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.1090
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Lucas Grason-Stadler, Inc.
- Date Received
- November 4, 1992
- Decision Date
- February 2, 1993
- Product Code
- ETY
- 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 |
|---|---|---|---|
| ETY | Tester, Auditory Impedance | FDA class 2 | Ear, Nose, Throat |
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