TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMN— 510(k) K903414

Clearance details

Applicant

Echo Ultrasound

Product code

Code DXK

Device class

Class 2

Regulation

21 CFR 870.2330

Advisory panel

Cardiovascular

Date received

1990-07-30

Decision date

1990-09-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Reedsville, PA, 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

• K924054 — PHONOCARDIOGRAPH1993-01-22
• K893225 — COUPLANT WARMING DEVICE1989-10-12
• K872519 — STERILIZED OMNI GEL1987-08-03
• K844034 — SONOCARE1985-01-23
• K844120 — ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS1985-01-23