SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM— 510(k) K981530

Name: FDA 510(k) clearance K981530
Creator: U.S. Food and Drug Administration
Published: 1998-11-20

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K981530 for SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM, Substantially Equivalent on 1998-11-20. Applicant: Spacelabs Medical, Inc.. Device class: 2.

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code BSZ
Device class: Class 2
Regulation: 21 CFR 868.5160
Advisory panel: Anesthesiology
Date received: 1998-04-29
Decision date: 1998-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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K093501 — ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION2009-11-24
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Adverse events under product code BSZ

product code BSZ

Death: 23
Injury: 298
Malfunction: 32,987
Total: 33,308

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.