PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE— 510(k) K001852

Substantially Equivalent

Itamar Medical (C.M.) 1997 , Ltd.

FDA 510(k) clearance K001852 for PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE, Substantially Equivalent on 2001-02-21. Applicant: Itamar Medical (C.M.) 1997 , Ltd..

Clearance details

Applicant: Itamar Medical (C.M.) 1997 , Ltd.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2000-06-19
Decision date: 2001-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ginot Shomron 44853, IL

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.