KENZ-ECG 102— 510(k) K863965

Clearance details

Applicant

Compumed, Inc.

Product code

Code DXK

Device class

Class 2

Regulation

21 CFR 870.2330

Advisory panel

Cardiovascular

Date received

1986-10-10

Decision date

1986-12-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Culver City, CA, US

• K181042 — Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter2018-05-17
• K160173 — Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)2016-02-26
• K031148 — IN-VISION IMAGING SYSTEM2003-05-28
• K934887 — 9750 ATHENA ETHERNET OPTION1994-01-14
• K913209 — ACCESSORY TO GENESIS III (GCFM)1992-05-15

• K984285 — OSTEOGRAM BONE DENSITOMETER1999-05-19
• K955708 — COMPUMED DICON CLIENT1996-03-01
• K854626 — COMPUMED PULMONARY FUNCTION ANALYZER MODEL 307B1986-02-28
• K802272 — COMPUTER ECG TERMINAL1980-09-26
• K771648 — COMPUTER ECG TERMINAL1977-09-20