510(k) K150530

Level Sensor, Level Sensor Tape by Medtronic, Inc. — Product Code DTW

K150530 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Level Sensor, Level Sensor Tape". The FDA issued a decision of Substantially Equivalent on May 8, 2015. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340. Medtronic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2015
Date Received
March 2, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
Review Panel
CV
Submission Type