The following data is part of a premarket notification filed by Yukosha Co., Inc. with the FDA for Yki-770 Electronic Sphygmomameter.
Device ID | K842318 |
510k Number | K842318 |
Device Name: | YKI-770 ELECTRONIC SPHYGMOMAMETER |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | YUKOSHA CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-06-12 |
Decision Date | 1985-02-14 |