FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR
K Number: K844216
·
Decision Jan 18, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
26
Applicant Total
6
Review Days
79
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Basic Information
- Device Name
- GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR
- K Number
- K844216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Grass Instrument Co.
- Date Received
- October 31, 1984
- Decision Date
- January 18, 1985
- Product Code
- JXE
- 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 |
|---|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | FDA class 2 | Neurology |
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|---|---|---|---|
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| K994142 | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM | Mar 6, 2000 | Substantially Equivalent |
| K812061 | MODEL S10VS VISUAL STIMULATOR | Aug 20, 1981 | Substantially Equivalent |
| K810539 | MODEL S10CTCM AUDITORY STIMULATOR | Mar 17, 1981 | Substantially Equivalent |
| K771742 | EVOKED RESPONSE SYS., MODEL 10 | Nov 22, 1977 | Substantially Equivalent |