FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 7320 VISUAL STIMULATOR
K Number: K781461
·
Decision Nov 8, 1978
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
48
Applicant Total
19
Review Days
82
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Basic Information
- Device Name
- MODEL 7320 VISUAL STIMULATOR
- K Number
- K781461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Life-Tech Instruments, Inc.
- Date Received
- August 18, 1978
- Decision Date
- November 8, 1978
- Product Code
- GWE
- 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 |
|---|---|---|---|
| GWE | Stimulator, Photic, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Life-Tech Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Sep 9, 1981 | Substantially Equivalent |
| K812179 | LIFE-TECH #1753 BIOFEEDBACK TRAINER | Aug 25, 1981 | Substantially Equivalent |
| K812180 | LIFE-TECH #5102 VISULAB | Aug 21, 1981 | Substantially Equivalent |
| K812178 | LIFE-TECH #'S 1106/1156 UROLABS | Aug 13, 1981 | Substantially Equivalent |
| K800112 | AMBLYOPIA TRAINER | Mar 10, 1980 | Substantially Equivalent |
| K790663 | MODEL 1750 STANDING URINAL | Apr 24, 1979 | Substantially Equivalent |
| K790664 | MODEL 1309 AUDIO MONITOR | Apr 23, 1979 | Substantially Equivalent |
| K781476 | MULAR GOLD LEAF ELECTRODE MODEL 7501 | Nov 15, 1978 | Substantially Equivalent |
| K781475 | ELECTRODE IMPEDANCE TESTER-MODEL 500 | Sep 7, 1978 | Substantially Equivalent |
| K781474 | PREAMPLIFIER MODELS 8101PI & 8102PI | Sep 7, 1978 | Substantially Equivalent |