FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED SONAMET BODY COMPOSITION ANALYZER
K Number: K032610
·
Decision Mar 1, 2004
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
2
Review Days
189
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Basic Information
- Device Name
- MODIFIED SONAMET BODY COMPOSITION ANALYZER
- K Number
- K032610
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Measurement, Inc.
- Date Received
- August 25, 2003
- Decision Date
- March 1, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAC), ordered by most recent decision date.
BOD POD
FDA 510(k)
FDA Class 2
·Cardiovascular
SONAMET BODY COMPOSITION ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Life Measurement, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060848 | BOD POD | Jun 27, 2006 | Substantially Equivalent |