510(k) K111542
K111542 is an FDA 510(k) premarket notification submitted by Deltex Medical Limited for the device "DELTEX MEDICAL CARDIOQ EDM". The FDA issued a decision of Substantially Equivalent on October 20, 2011. 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
- October 20, 2011
- Date Received
- June 2, 2011
- 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