The following data is part of a premarket notification filed by Canamet Canadian Natl Medical Technologies, Inc. with the FDA for Piesometer, Model Mk-1.
Device ID | K041169 |
510k Number | K041169 |
Device Name: | PIESOMETER, MODEL MK-1 |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. P.O. BOX 7007 Deerfield, IL 60015 |
Contact | Daniel Kamm |
Correspondent | Daniel Kamm CANAMET CANADIAN NATL MEDICAL TECHNOLOGIES, INC. P.O. BOX 7007 Deerfield, IL 60015 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-05-04 |
Decision Date | 2004-08-24 |
Summary: | summary |