The following data is part of a premarket notification filed by Medtronic, Inc with the FDA for Level Sensor, Level Sensor Tape.
Device ID | K150530 |
510k Number | K150530 |
Device Name: | Level Sensor, Level Sensor Tape |
Classification | Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass |
Applicant | Medtronic, Inc 7611 Northland Drive Minneapolis, MN 55428 |
Contact | Rahul Shah |
Correspondent | Rahul Shah Medtronic, Inc 7611 Northland Drive Minneapolis, MN 55428 |
Product Code | DTW |
CFR Regulation Number | 870.4340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-03-02 |
Decision Date | 2015-05-08 |
Summary: | summary |