FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DYNATRON 330 BODY COMPOSITION ANALYZER
K Number: K900321
·
Decision Jun 11, 1990
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
113
Applicant Total
5
Review Days
139
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Basic Information
- Device Name
- DYNATRON 330 BODY COMPOSITION ANALYZER
- K Number
- K900321
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Dynatronics Laser Corp.
- Date Received
- January 23, 1990
- Decision Date
- June 11, 1990
- Product Code
- DSB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSB | Plethysmograph, Impedance | FDA class 2 | Cardiovascular |
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Other Clearances by Dynatronics Laser Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K920939 | DYNATRON 300 ULRASOUND | Mar 4, 1993 | Substantially Equivalent |
| K900639 | DYNATRON 350 EMG/BIOFEEDBACK ANALYZER | Oct 4, 1990 | Substantially Equivalent |
| K880464 | DYNATRON II | Mar 8, 1988 | Substantially Equivalent |
| K864370 | DYNATRON 1120 EPS (ELECTRICAL POINT STIMULATOR) | Apr 10, 1987 | Substantially Equivalent for Some Indications |