SPACELABS ARRHYTHMIA NET (TM) LEVEL 2— 510(k) K864505

Name: FDA 510(k) clearance K864505
Creator: U.S. Food and Drug Administration
Published: 1986-11-24

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K864505 for SPACELABS ARRHYTHMIA NET (TM) LEVEL 2, Substantially Equivalent on 1986-11-24. Applicant: Spacelabs, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code DSI
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1986-11-14
Decision date: 1986-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chatsworth, CA, US

Download summary PDF View on FDA.gov ↗

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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 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.