FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THERMOTRON 918
K Number: K860082
·
Decision Mar 27, 1986
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
1
Review Days
78
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Basic Information
- Device Name
- THERMOTRON 918
- K Number
- K860082
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5275
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Medical Microwave Research Corp.
- Date Received
- January 8, 1986
- Decision Date
- March 27, 1986
- Product Code
- IOA
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IOA | Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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