The following data is part of a premarket notification filed by Par Medizintechnik Gmbh & Co. Kg with the FDA for Tonoport Vi.
Device ID | K170966 |
510k Number | K170966 |
Device Name: | TONOPORT VI |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | PAR Medizintechnik GmbH & Co. KG Sachsendamm 6 Berlin, DE 10829 |
Contact | Buelent Tek |
Correspondent | Thomas Fischer PAR Medizintechnik GmbH & Co. KG Sachsendamm 6 Berlin, DE 10829 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-31 |
Decision Date | 2017-06-14 |
Summary: | summary |