The following data is part of a premarket notification filed by Medtronic Inc. with the FDA for Bio-probe Transducer (adult).
Device ID | K133903 |
510k Number | K133903 |
Device Name: | BIO-PROBE TRANSDUCER (ADULT) |
Classification | Probe, Blood-flow, Extravascular |
Applicant | MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Contact | Rahul Shah |
Correspondent | Rahul Shah MEDTRONIC INC. 8200 Coral Sea Street NE Mounds View, MN 55112 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-20 |
Decision Date | 2014-04-10 |
Summary: | summary |