ViaTherm BOOST
FDA 510(k) clearance K173300 · decided 2018-05-01
Clearance details
- K-number
- K173300
- Device name
- ViaTherm BOOST
- Applicant
- Viatherm Therapeutics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-10-17
- Decision date
- 2018-05-01
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- IMJ
- Device class
- 2
- Regulation number
- 890.5290
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Annapolis, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.