HRV ACQUIRE— 510(k) K092809

Substantially Equivalent

Wr Medical Electronics Co.

FDA 510(k) clearance K092809 for HRV ACQUIRE, Substantially Equivalent on 2010-10-19. Applicant: Wr Medical Electronics Co..

Clearance details

Applicant: Wr Medical Electronics Co.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 2009-09-11
Decision date: 2010-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Stoughton, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.