FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOLATED VOLTAGE/FREQUENCY CONVERTER
K Number: K812619
·
Decision Oct 8, 1981
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
11
Review Days
23
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Basic Information
- Device Name
- ISOLATED VOLTAGE/FREQUENCY CONVERTER
- K Number
- K812619
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Bio-Feedback Systems, Inc.
- Date Received
- September 15, 1981
- Decision Date
- October 8, 1981
- 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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Other Clearances by Bio-Feedback Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K905372 | MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002 | Apr 12, 1991 | Substantially Equivalent |
| K905373 | MINIATURE TEMPERATURE TRAINER MODEL DT-002 | Apr 10, 1991 | Substantially Equivalent |
| K900063 | MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA) | Feb 16, 1990 | Substantially Equivalent |
| K860914 | ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV | Jun 6, 1986 | Substantially Equivalent |
| K832333 | FEEDBACK EMG SYSTEM PE-020 | Sep 1, 1983 | Substantially Equivalent |
| K792659 | FEEDBACK EDR SYSTEM MODEL ME-1 | Jan 9, 1980 | Substantially Equivalent |
| K771023 | ANALOG QUANTIFIER MODEL AQ-100 | Jun 24, 1977 | Substantially Equivalent |
| K770790 | FEEDBACK EDR SYSTEM MODEL EDR-100 | May 10, 1977 | Substantially Equivalent |
| K770663 | FEEDBACK EMG SYSTEM, MODEL PE-L00 | Apr 26, 1977 | Substantially Equivalent |
| K770270 | TEMPERATURE FEEDBACK SYS, MODEL DT100 | Feb 24, 1977 | Substantially Equivalent |