FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EIM-107 PREP-CHECK
K Number: K993202
·
Decision Dec 17, 1999
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
25
Applicant Total
13
Review Days
84
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Basic Information
- Device Name
- EIM-107 PREP-CHECK
- K Number
- K993202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1540
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- General Devices
- Date Received
- September 24, 1999
- Decision Date
- December 17, 1999
- Product Code
- GZO
- 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 |
|---|---|---|---|
| GZO | Device, Galvanic Skin Response Measurement | FDA class 2 | Neurology |
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