The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Blood Pressure Transducer.
Device ID | K123095 |
510k Number | K123095 |
Device Name: | MEDLINE BLOOD PRESSURE TRANSDUCER |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Contact | Matt Clausen |
Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-02 |
Decision Date | 2013-05-08 |