PRIMUS INTER PARESECHOCARDIOGRAPHY SYS.— 510(k) K770073

Name: FDA 510(k) clearance K770073
Creator: U.S. Food and Drug Administration
Published: 1977-01-25

Substantially Equivalent

Rohe Scientific Corp.

FDA 510(k) clearance K770073 for PRIMUS INTER PARESECHOCARDIOGRAPHY SYS., Substantially Equivalent on 1977-01-25. Applicant: Rohe Scientific Corp.. Device class: 2.

Clearance details

Applicant: Rohe Scientific Corp.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1977-01-13
Decision date: 1977-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXK

view all

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

More clearances from Rohe Scientific Corp.

view all

K810038 — DIGITAL DIAGNOSTIC ULTRASOUND DEVICE1981-04-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.