FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
K Number: K861837
·
Decision Aug 7, 1986
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
54
Applicant Total
3
Review Days
86
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Basic Information
- Device Name
- FISCHER/KRYSTAL THERAPEUTIC ULTRASOUND
- K Number
- K861837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5860
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Fischer Industries, Inc.
- Date Received
- May 13, 1986
- Decision Date
- August 7, 1986
- 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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