ANESTHESIA WORKSTATION— 510(k) K901474

Substantially Equivalent

Siemens Life Support Systems

FDA 510(k) clearance K901474 for ANESTHESIA WORKSTATION, Substantially Equivalent on 1990-04-10. Applicant: Siemens Life Support Systems. Device class: 1.

Clearance details

Applicant
Siemens Life Support Systems
Product code
Code BRY
Device class
Class 1
Regulation
21 CFR 868.6100
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Schaumburg, IL, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BRY

product code BRY
Death
9
Malfunction
75,890
Total
75,899

Source: openFDA MAUDE database, through . 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.