FINGER PULSE METER— 510(k) K000814

Substantially Equivalent

Bhs Intl., Inc.

FDA 510(k) clearance K000814 for FINGER PULSE METER, Substantially Equivalent on 2001-03-29. Applicant: Bhs Intl., Inc..

Clearance details

Applicant: Bhs Intl., Inc.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2000-03-13
Decision date: 2001-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.