FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SONAMET BODY COMPOSITION ANALYZER
K Number: K924972
·
Decision Feb 13, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
1
Review Days
866
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Basic Information
- Device Name
- SONAMET BODY COMPOSITION ANALYZER
- K Number
- K924972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Life Measurement Instruments, Inc.
- Date Received
- September 30, 1992
- Decision Date
- February 13, 1995
- Product Code
- OAC
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| OAC | Plethysmograph, Air Displacement For Body Composition Analysis | FDA class 2 | Cardiovascular |
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