FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMFORTRON
K Number: K862092
·
Decision Oct 15, 1986
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
3
Review Days
135
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Basic Information
- Device Name
- COMFORTRON
- K Number
- K862092
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- M. D. Supply, Inc.
- Date Received
- June 2, 1986
- Decision Date
- October 15, 1986
- Product Code
- KZM
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| KZM | Device, Muscle Monitoring | FDA class 2 | Physical Medicine |
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