ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR— 510(k) K890408

Name: FDA 510(k) clearance K890408
Creator: U.S. Food and Drug Administration
Published: 1989-06-01

Substantially Equivalent

Bomed Medical Mfg., Ltd.

FDA 510(k) clearance K890408 for ADDITIONAL SOFTWARE TO CARDIODYNAMIC MONITOR, Substantially Equivalent on 1989-06-01. Applicant: Bomed Medical Mfg., Ltd.. Device class: 2.

Clearance details

Applicant: Bomed Medical Mfg., Ltd.
Product code: Code DSB
Device class: Class 2
Regulation: 21 CFR 870.2770
Advisory panel: Cardiovascular
Date received: 1989-01-24
Decision date: 1989-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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