ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841— 510(k) K992749

Substantially Equivalent

Spacelabs Medical, Inc.

FDA 510(k) clearance K992749 for ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841, Substantially Equivalent on 2000-01-14. Applicant: Spacelabs Medical, Inc..

Clearance details

Applicant: Spacelabs Medical, Inc.
Product code: Code MSX
Advisory panel: Cardiovascular
Date received: 1999-08-16
Decision date: 2000-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redmond, WA, US

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Adverse events under product code MSX

product code MSX

Death: 59
Total: 59

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.