GENESIS III, (MOD. 7003/7004)— 510(k) K894370

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K894370 for GENESIS III, (MOD. 7003/7004), Substantially Equivalent on 1990-01-29. Applicant: Biosound, Inc.. Device class: 2.

Clearance details

Applicant: Biosound, Inc.
Product code: Code DXK
Device class: Class 2
Regulation: 21 CFR 870.2330
Advisory panel: Cardiovascular
Date received: 1989-07-14
Decision date: 1990-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXK

More clearances from Biosound, Inc.

K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER1997-07-09
K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER1997-03-31
K963262 — ARTOSCAN M1997-03-28
K963662 — GALILEO EVOKED POTENTIALRE1997-02-26
K953716 — INTRACAVITY TRANSDUCERS1996-04-17

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