SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM— 510(k) K951605

Name: FDA 510(k) clearance K951605
Creator: U.S. Food and Drug Administration
Published: 1995-07-14

Substantially Equivalent

Spacelabs, Inc.

FDA 510(k) clearance K951605 for SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM, Substantially Equivalent on 1995-07-14. Applicant: Spacelabs, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs, Inc.
Product code: Code DSH
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 1995-04-07
Decision date: 1995-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, 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
K950779 — HEART RATE VARIABILITY SOFTWARE OPTION1995-04-25
K941165 — COMET CAPNOGRAPH MODULE1994-10-06
K923788 — SPACE LABS MODEL 905601993-12-06
K912742 — ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE1992-04-20

Adverse events under product code DSH

product code DSH

Death: 3
Injury: 652
Total: 655

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.