FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
ULTRA V THERAPEUTIC ULTRASOUND
K Number: K001166
·
Decision Jul 7, 2000
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
53
Applicant Total
58
Review Days
88
Basic Information
- Device Name
- ULTRA V THERAPEUTIC ULTRASOUND
- K Number
- K001166
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EXCEL TECH. LTD.
- Date Received
- April 10, 2000
- Decision Date
- July 7, 2000
- Product Code
- IMG
- 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 |
|---|---|---|---|
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | FDA class 2 | Physical Medicine |
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