TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
FDA 510(k) clearance K040778 · decided 2004-12-23
Clearance details
- K-number
- K040778
- Device name
- TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
- Applicant
- Tanita Corp. of America
- Decision
- Substantially Equivalent
- Date received
- 2004-03-26
- Decision date
- 2004-12-23
- Days to decision
- 272 days
- Clearance type
- Traditional
- Product code
- MNW
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arlington Heights, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.