FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNATRON 900
K Number: K993919
·
Decision Jan 3, 2000
Classifications
1
FEI Numbers
16
Registration Numbers
16
Same Product Code
70
Applicant Total
24
Review Days
46
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Basic Information
- Device Name
- DYNATRON 900
- K Number
- K993919
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5900
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dynatronics Corp.
- Date Received
- November 18, 1999
- Decision Date
- January 3, 2000
- Product Code
- ITH
- 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 |
|---|---|---|---|
| ITH | Equipment, Traction, Powered | FDA class 2 | Physical Medicine |
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| K031329 | DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) | Oct 22, 2003 | Substantially Equivalent |
| K010948 | DYNATRON STS RX | May 15, 2001 | Substantially Equivalent |
| K010565 | DYNATRON STS | May 15, 2001 | Substantially Equivalent |