BODYMETRIX BX2000
FDA 510(k) clearance K082147 · decided 2009-03-20
Clearance details
- K-number
- K082147
- Device name
- BODYMETRIX BX2000
- Applicant
- Intelametrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-07-30
- Decision date
- 2009-03-20
- Days to decision
- 233 days
- Clearance type
- Traditional
- Product code
- OMV
- Device class
- 2
- Regulation number
- 870.2770
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Livermore, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.