FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHAONE BIOFEEDBACK SYSTEM
K Number: K071661
·
Decision Sep 5, 2007
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
14
Review Days
78
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Basic Information
- Device Name
- ALPHAONE BIOFEEDBACK SYSTEM
- K Number
- K071661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Telediagnostic Systems, Inc.
- Date Received
- June 19, 2007
- Decision Date
- September 5, 2007
- Product Code
- HCC
- 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 |
|---|---|---|---|
| HCC | Device, Biofeedback | FDA class 2 | Neurology |
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| K874257 | S-10 TELEPHONIC POLYSOMNOGRAPH | Dec 11, 1987 | Substantially Equivalent |
| K871120 | M10 EEG MONITOR SCOPE | May 1, 1987 | Substantially Equivalent |
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