FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MONITOR, GSR (NB-401)
K Number: K760084
·
Decision Jul 26, 1976
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
171
Applicant Total
9
Review Days
35
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Basic Information
- Device Name
- MONITOR, GSR (NB-401)
- K Number
- K760084
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5050
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Narco Bio-Systems
- Date Received
- June 21, 1976
- Decision Date
- July 26, 1976
- 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 Narco Bio-Systems
| K Number | Device Name | ||
|---|---|---|---|
| K853683 | UMS-100 | Jan 10, 1986 | Substantially Equivalent |
| K833656 | NARCOTRACE 40 - NT40 | May 9, 1984 | Substantially Equivalent |
| K832869 | MOTILITY MEASUREMENT SYS MMS-100 | Oct 31, 1983 | Substantially Equivalent |
| K813502 | NARCO TELECARE ISOFLO PRESSURE MONITOR | Dec 29, 1981 | Substantially Equivalent |
| K811376 | ULTRASONIC QFM SYSTEM 1000 | Aug 13, 1981 | Substantially Equivalent |
| K810431 | NARCO TLECARE MINIATURE PRESSURE DOME | Mar 11, 1981 | Substantially Equivalent |
| K801544 | PORTA-FIB LPD | Jul 14, 1980 | Substantially Equivalent |
| K760083 | PHYSIOSCOPE | Jul 20, 1976 | Substantially Equivalent |