FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ASC-954 INTEGRATOR AMPLIFIER
K Number: K896164
·
Decision Jan 22, 1990
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
22
Applicant Total
13
Review Days
90
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Basic Information
- Device Name
- ASC-954 INTEGRATOR AMPLIFIER
- K Number
- K896164
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1845
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Astro-Med, Inc.
- Date Received
- October 24, 1989
- Decision Date
- January 22, 1990
- Product Code
- GWK
- 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 |
|---|---|---|---|
| GWK | Conditioner, Signal, Physiological | FDA class 2 | Neurology |
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