510(k) K142207
K142207 is an FDA 510(k) premarket notification submitted by Eppendorf AG for the device "TransferMan 4m Micromanipulator". The FDA issued a decision of Substantially Equivalent on January 23, 2015. The device falls under product code MQJ (Micromanipulators And Microinjectors, Assisted Reproduction), a Class II device regulated under 21 CFR 884.6150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2015
- Date Received
- August 11, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Micromanipulators And Microinjectors, Assisted Reproduction
- Device Class
- Class II
- Regulation Number
- 884.6150
- Review Panel
- OB
- Submission Type