510(k) K030961
K030961 is an FDA 510(k) premarket notification submitted by Microlife Corp. for the device "MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921". The FDA issued a decision of Substantially Equivalent on September 12, 2003. The device falls under product code LHD (Device, Fertility Diagnostic, Proceptive), a Class U device. Microlife Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 2003
- Date Received
- March 27, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Fertility Diagnostic, Proceptive
- Device Class
- Class U
- Regulation Number
- Review Panel
- OB
- Submission Type