The following data is part of a premarket notification filed by Sybron Corp. with the FDA for Tycos Self Check Bpm3 Blood Press Moni.
Device ID | K840469 |
510k Number | K840469 |
Device Name: | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | SYBRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-02-03 |
Decision Date | 1984-05-21 |