GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER— 510(k) K881723

Name: FDA 510(k) clearance K881723
Creator: U.S. Food and Drug Administration
Published: 1988-08-12

Substantially Equivalent

Biosound, Inc.

FDA 510(k) clearance K881723 for GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER, Substantially Equivalent on 1988-08-12. Applicant: Biosound, Inc.. Device class: 2.

Clearance details

Applicant: Biosound, Inc.
Product code: Code JOP
Device class: Class 2
Regulation: 21 CFR 870.2880
Advisory panel: Cardiovascular
Date received: 1988-04-21
Decision date: 1988-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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K963662 — GALILEO EVOKED POTENTIALRE1997-02-26
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