The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Klock Watch Style Digital Blood Pressure Monitor.
Device ID | K023356 |
510k Number | K023356 |
Device Name: | KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR |
Classification | Blood Pressure Cuff |
Applicant | CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
Contact | Alex Gonorovsky |
Correspondent | Alex Gonorovsky CARD GUARD SCIENTIFIC SURVIVAL, LTD. 2 PEKERIS ST. Rehovot, IL 76100 |
Product Code | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-07 |
Decision Date | 2003-01-16 |