HOLTER 6000— 510(k) K950988

Substantially Equivalent

Omega Medical Services, Inc.

FDA 510(k) clearance K950988 for HOLTER 6000, Substantially Equivalent on 1996-01-04. Applicant: Omega Medical Services, Inc..

Clearance details

Applicant: Omega Medical Services, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 1995-03-03
Decision date: 1996-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Myers, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

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.