QUINTON MODEL 630 AND 636 ECG DATA CART— 510(k) K791364

Name: FDA 510(k) clearance K791364
Creator: U.S. Food and Drug Administration
Published: 1979-08-03

Substantially Equivalent

Quinton, Inc.

FDA 510(k) clearance K791364 for QUINTON MODEL 630 AND 636 ECG DATA CART, Substantially Equivalent on 1979-08-03. Applicant: Quinton, Inc.. Device class: 2.

Clearance details

Applicant: Quinton, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1979-07-10
Decision date: 1979-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Quinton, Inc.

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K032038 — PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 926012003-09-05
K021906 — QUINTON Q-CATH, MODEL 0004602002-09-04
K003576 — Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 0005032001-01-25
K001492 — QUINTON Q-STRESS, MODEL 0004832000-08-09
K992908 — Q-TEL TELEMETRY SYSTEM V. 6.0 (ST)2000-03-06

Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.