510(k) K211969
K211969 is an FDA 510(k) premarket notification submitted by Exact Medical Manufacturing for the device "EMM Ultrasonic Transducer Cover". The FDA issued a decision of Substantially Equivalent on Aug 13, 2021. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Exact Medical Manufacturing has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2021
- Date Received
- Jun 24, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type
- 510(k)