higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
FDA 510(k) clearance K172739 · decided 2017-10-10
Clearance details
- K-number
- K172739
- Device name
- higi Station (with Body Composition and Pan and Tilt cuff housing), higi Station ( with Body Composition and Fixed cuff housing)
- Applicant
- Higi Sh, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-09-12
- Decision date
- 2017-10-10
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Monrovia, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.