FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPERATURE FEEDBACK SYS, MODEL DT100
K Number: K770270
·
Decision Feb 24, 1977
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
11
Review Days
13
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Basic Information
- Device Name
- TEMPERATURE FEEDBACK SYS, MODEL DT100
- K Number
- K770270
- 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
- February 11, 1977
- Decision Date
- February 24, 1977
- 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 |
| 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 |