510(k) K150347
K150347 is an FDA 510(k) premarket notification submitted by Deltex Medical Limited for the device "Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+". The FDA issued a decision of Substantially Equivalent on July 24, 2015. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Deltex Medical Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 24, 2015
- Date Received
- February 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type