SPACELABS-GENERAL SYSTEM LINK— 510(k) K850627

Name: FDA 510(k) clearance K850627
Creator: U.S. Food and Drug Administration
Published: 1985-05-28

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K850627 for SPACELABS-GENERAL SYSTEM LINK, Substantially Equivalent on 1985-05-28. Applicant: Spacelabs, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 1985-02-19
Decision date: 1985-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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K252978 — ScioCardio ECG Analysis Platform2026-07-09

More clearances from Spacelabs, Inc.

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K954962 — SPACELABS MEDICAL MULTIGAS ANALYZER1996-05-31
K951605 — SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM1995-07-14
K950779 — HEART RATE VARIABILITY SOFTWARE OPTION1995-04-25
K941165 — COMET CAPNOGRAPH MODULE1994-10-06
K923788 — SPACE LABS MODEL 905601993-12-06

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.