510(k) K082147
- Device
- BODYMETRIX BX2000
- Applicant
- INTELAMETRIX, INC
- 510(k) number
- K082147
- Product code
- OMV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-20
- Date received
- 2008-07-30
- Regulation
- 870.2770
- Classification name
- Ultrasonic Body Composition Analyzer
- Medical specialty
- Cardiovascular
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- HEIDI STARK
- Address
- 6246 Preston Ave. Livermore CA US 94551 94551
FDA Registration Numbers#
- 3015973732
- 3004977335
Source Documents#
Legacy Summary#
summary
FDA Review#
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