510(k) K073401
K073401 is an FDA 510(k) premarket notification submitted by Micromedics, Inc. for the device "EARPOPPER, MODEL EP-2000, EP-2100, EP-3000". The FDA issued a decision of Substantially Equivalent on March 14, 2008. The device falls under product code MJV (Device, Inflation, Middle Ear), a Class U device. Micromedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 2008
- Date Received
- December 4, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Inflation, Middle Ear
- Device Class
- Class U
- Regulation Number
- Review Panel
- EN
- Submission Type