FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV
K Number: K860914
·
Decision Jun 6, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
22
Applicant Total
11
Review Days
87
Basic Information
- Device Name
- ISOLATED SOLID-STATE RELAY MULTIPLEXER & F/F CONV
- K Number
- K860914
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1845
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- BIO-FEEDBACK SYSTEMS, INC.
- Date Received
- March 11, 1986
- Decision Date
- June 6, 1986
- 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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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 |
| K832333 | FEEDBACK EMG SYSTEM PE-020 | Sep 1, 1983 | Substantially Equivalent |
| K812619 | ISOLATED VOLTAGE/FREQUENCY CONVERTER | Oct 8, 1981 | 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 |