HYPOTHERMX INTRAVENOUS FLUID WARMER
FDA 510(k) clearance K103801 · decided 2011-05-20
Clearance details
- K-number
- K103801
- Device name
- HYPOTHERMX INTRAVENOUS FLUID WARMER
- Applicant
- Emit Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-12-28
- Decision date
- 2011-05-20
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- LGZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Woodlands, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.