FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL S10CTCM AUDITORY STIMULATOR
K Number: K810539
·
Decision Mar 17, 1981
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
75
Applicant Total
6
Review Days
18
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Basic Information
- Device Name
- MODEL S10CTCM AUDITORY STIMULATOR
- K Number
- K810539
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1900
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Grass Instrument Co.
- Date Received
- February 27, 1981
- Decision Date
- March 17, 1981
- Product Code
- GWJ
- 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 |
|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | FDA class 2 | Neurology |
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Other Clearances by Grass Instrument Co.
| K Number | Device Name | ||
|---|---|---|---|
| K021807 | GRASS-TELEFACTOR AS40 AMPLIFIER SYSTEM | Aug 29, 2002 | Substantially Equivalent |
| K994142 | GRASS TS3201/6401 EEG AMPLIFIER SYSTEM | Mar 6, 2000 | Substantially Equivalent |
| K844216 | GRASS MODEL NL FACIAL NERVE LOCATOR & MONITOR | Jan 18, 1985 | Substantially Equivalent |
| K812061 | MODEL S10VS VISUAL STIMULATOR | Aug 20, 1981 | Substantially Equivalent |
| K771742 | EVOKED RESPONSE SYS., MODEL 10 | Nov 22, 1977 | Substantially Equivalent |