FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
K Number: K122388
·
Decision May 2, 2013
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
78
Applicant Total
2
Review Days
269
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Basic Information
- Device Name
- SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
- K Number
- K122388
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Seca GmbH & Co. KG
- Date Received
- August 6, 2012
- Decision Date
- May 2, 2013
- Product Code
- MNW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MNW | Analyzer, Body Composition | FDA class 2 | Cardiovascular |
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Other Clearances by Seca GmbH & Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K192092 | Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 | Jan 23, 2020 | Substantially Equivalent |