FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇷 Brazil
BODYSTAT
K Number: K971554
·
Decision Nov 26, 1997
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
78
Applicant Total
8
Review Days
210
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Basic Information
- Device Name
- BODYSTAT
- K Number
- K971554
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bodystat , Ltd.
- Date Received
- April 30, 1997
- Decision Date
- November 26, 1997
- 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 Bodystat , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K082254 | MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT | Feb 7, 2011 | Substantially Equivalent |
| K082255 | QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT | Feb 7, 2011 | Substantially Equivalent |
| K082253 | BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT | Nov 25, 2008 | Substantially Equivalent |
| K002835 | BODYSTAT | Jul 3, 2001 | Substantially Equivalent |
| K994242 | BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT | Mar 15, 2000 | Substantially Equivalent |
| K980971 | BODYSTAT DUALSCAN 2005 | Jun 11, 1998 | Substantially Equivalent |
| K951097 | BODYSTAY | Nov 22, 1995 | Substantially Equivalent |