BIOHARNESS— 510(k) K100040

Substantially Equivalent

Zephyr Technology Corporation

FDA 510(k) clearance K100040 for BIOHARNESS, Substantially Equivalent on 2010-12-03. Applicant: Zephyr Technology Corporation.

Clearance details

Applicant: Zephyr Technology Corporation
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2010-01-07
Decision date: 2010-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Annapolis, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.