FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHA-STIM CS
K Number: K903014
·
Decision May 12, 1992
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
18
Applicant Total
5
Review Days
672
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Basic Information
- Device Name
- ALPHA-STIM CS
- K Number
- K903014
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5800
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Electromedical Products, Inc.
- Date Received
- July 10, 1990
- Decision Date
- May 12, 1992
- Product Code
- QJQ
- 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 |
|---|---|---|---|
| QJQ | Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety | FDA class 2 | Neurology |
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