FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
COMFORTRON II (TENS)
K Number: K902948
·
Decision Dec 17, 1990
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
14
Applicant Total
3
Review Days
165
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Basic Information
- Device Name
- COMFORTRON II (TENS)
- K Number
- K902948
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- M. D. Products
- Date Received
- July 5, 1990
- Decision Date
- December 17, 1990
- Product Code
- LWM
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| LWM | Device, Electrical Dental Anesthesia | FDA unclassified | Unknown |
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