FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT
K Number: K850640
·
Decision May 14, 1985
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
88
Applicant Total
3
Review Days
84
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Basic Information
- Device Name
- SONOPULS 434 ULTRASOUND THERAPY EQUIPMENT
- K Number
- K850640
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5300
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fluidotherapy Corp.
- Date Received
- February 19, 1985
- Decision Date
- May 14, 1985
- Product Code
- IMI
- 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 |
|---|---|---|---|
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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