SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE— 510(k) K003663

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K003663 for SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE, Substantially Equivalent on 2001-06-28. Applicant: Spacelabs Medical, Inc..

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code BSZ
Advisory panel: Anesthesiology
Date received: 2000-11-28
Decision date: 2001-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

Download summary PDF View on FDA.gov ↗

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.