510(k) K220490
K220490 is an FDA 510(k) premarket notification submitted by Imacor, Inc. for the device "ImaCor Zura Handheld ZHH-010". The FDA issued a decision of Substantially Equivalent on April 8, 2022. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Imacor, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 2022
- Date Received
- February 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Device Class
- Class II
- Regulation Number
- 892.1550
- Review Panel
- RA
- Submission Type