MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
FDA 510(k) clearance K050197 · decided 2006-10-06
Clearance details
- K-number
- K050197
- Device name
- MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045
- Applicant
- Minitube of America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-01-27
- Decision date
- 2006-10-06
- Days to decision
- 617 days
- Clearance type
- Traditional
- Product code
- MQG
- Device class
- 2
- Regulation number
- 884.6120
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Madison, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.