The following data is part of a premarket notification filed by Card Guard Scientific Survival, Ltd. with the FDA for Pmp4 Bp Pro Blood Pressure Monitor.
Device ID | K060703 |
510k Number | K060703 |
Device Name: | PMP4 BP PRO BLOOD PRESSURE MONITOR |
Classification | System, Measurement, Blood-pressure, Non-invasive |
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 | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-16 |
Decision Date | 2006-04-04 |
Summary: | summary |