FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOMATICS MOUTH GUARD (BITE BLOCK)
K Number: K864181
·
Decision Nov 3, 1986
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
27
Applicant Total
7
Review Days
7
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Basic Information
- Device Name
- SOMATICS MOUTH GUARD (BITE BLOCK)
- K Number
- K864181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5070
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Somatics, Inc.
- Date Received
- October 27, 1986
- Decision Date
- November 3, 1986
- Product Code
- JXL
- 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 |
|---|---|---|---|
| JXL | Block, Bite | FDA class 2 | Neurology |
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Other Clearances by Somatics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992269 | VENTIL-A ORAL PROTECTOR | Oct 25, 1999 | Substantially Equivalent |
| K945120 | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | Oct 26, 1995 | Substantially Equivalent |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | Jun 2, 1989 | Substantially Equivalent |
| K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | Mar 14, 1989 | Substantially Equivalent |
| K882809 | THYMAPAD | Sep 27, 1988 | Substantially Equivalent |
| K843923 | THYMATRON | Dec 3, 1984 | Substantially Equivalent |