The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Transducer, Pressure, Catheter Tip.
Device ID | K920580 |
510k Number | K920580 |
Device Name: | TRANSDUCER, PRESSURE, CATHETER TIP |
Classification | Transducer, Pressure, Catheter Tip |
Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
Contact | Timothy H Tucker |
Correspondent | Timothy H Tucker MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
Product Code | DXO |
CFR Regulation Number | 870.2870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-02-10 |
Decision Date | 1993-01-07 |