6200 VITAL SIGNS MONITOR— 510(k) K953415

Substantially Equivalent

Bci Intl., Inc.

FDA 510(k) clearance K953415 for 6200 VITAL SIGNS MONITOR, Substantially Equivalent on 1995-10-19. Applicant: Bci Intl., Inc..

Clearance details

Applicant: Bci Intl., Inc.
Product code: Code DPS
Advisory panel: Cardiovascular
Date received: 1995-07-20
Decision date: 1995-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.