TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT)— 510(k) K962128

Name: FDA 510(k) clearance K962128
Creator: U.S. Food and Drug Administration
Published: 1996-11-21

Substantially Equivalent

Hemo Sapiens, Inc.

FDA 510(k) clearance K962128 for TEBCO (THORACIC ELECTRICAL BIOIMPEDANCE CARDIAC OUTPUT), Substantially Equivalent on 1996-11-21. Applicant: Hemo Sapiens, Inc.. Device class: 2.

Clearance details

Applicant: Hemo Sapiens, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1996-06-03
Decision date: 1996-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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