FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
K Number: K033157
·
Decision Apr 8, 2004
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
78
Applicant Total
6
Review Days
191
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Basic Information
- Device Name
- TANITA SEGMENTAL BODY COMPOSITION ANALYZER, MODEL BC-418
- K Number
- K033157
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tanita Corp. of America
- Date Received
- September 30, 2003
- Decision Date
- April 8, 2004
- 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 Tanita Corp. of America
| K Number | Device Name | ||
|---|---|---|---|
| K040778 | TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) | Dec 23, 2004 | Substantially Equivalent |
| K040978 | TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE | Jul 22, 2004 | Substantially Equivalent |
| K014009 | TANITA BODY COMPOSITION ANALYZER; TANITA BODY FAT MONITOR; TANITA ULTIMATE SCALE | Jun 24, 2002 | Substantially Equivalent |
| K930599 | BODY FAT ANALYZER MODEL TBF-105 | Nov 1, 1994 | Substantially Equivalent |
| K932572 | DIGITAL BABY SCALE MODEL BLB-12 | Nov 16, 1993 | Substantially Equivalent |