510(k) K050197
K050197 is an FDA 510(k) premarket notification submitted by Minitube of America, Inc. for the device "MINITUBE TEMPERATURE CONTROL UNIT SC-2000 + 2045". The FDA issued a decision of Substantially Equivalent on October 6, 2006. The device falls under product code MQG (Accessory, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6120. Minitube of America, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 6, 2006
- Date Received
- January 27, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6120
- Review Panel
- OB
- Submission Type