MYOHEALTH CLENCHING INHIBITOR— 510(k) K040315

Substantially Equivalent

Mci-Myohealth Systems

FDA 510(k) clearance K040315 for MYOHEALTH CLENCHING INHIBITOR, Substantially Equivalent on 2004-08-27. Applicant: Mci-Myohealth Systems.

Clearance details

Applicant
Mci-Myohealth Systems
Product code
Code MQC
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mission Viejo, CA, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code MQC

product code MQC
Injury
377
Total
377

Source: openFDA MAUDE database, through . 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.