STOCKERT HEATER-COOLER SYSTEM 3T
FDA 510(k) clearance K052601 · decided 2006-06-06
Clearance details
- K-number
- K052601
- Device name
- STOCKERT HEATER-COOLER SYSTEM 3T
- Applicant
- Sorin Group Deutschland GmbH
- Decision
- Substantially Equivalent
- Date received
- 2005-09-21
- Decision date
- 2006-06-06
- Days to decision
- 258 days
- Clearance type
- Traditional
- Product code
- DWC
- Device class
- 2
- Regulation number
- 870.4250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- North Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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