FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR— 510(k) K853352

Name: FDA 510(k) clearance K853352
Creator: U.S. Food and Drug Administration
Published: 1985-11-14

Substantially Equivalent

Fukuda Denshi USA, Inc.

FDA 510(k) clearance K853352 for FUKUDA DENSHI DS-1060 DYNASCOPE PATIENT MONITOR, Substantially Equivalent on 1985-11-14. Applicant: Fukuda Denshi USA, Inc.. Device class: 2.

Clearance details

Applicant: Fukuda Denshi USA, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1985-08-12
Decision date: 1985-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kirkland, WA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Fukuda Denshi USA, Inc.

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K173226 — CardiMax Electrocardiograph2018-04-16
K150030 — Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor2015-03-16
K134046 — FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR2015-02-12
K112521 — FUKUDA DENSHI VASERA MODEL VS-15002011-12-21
K103134 — FUKUDA DENSHI2011-03-11

Adverse events under product code DSI

product code DSI

Death: 170
Injury: 729
Malfunction: 10,680
Total: 11,579

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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