510(k) K052804— BREATHKEY MODEL G10/BREATHKEY MODEL G30X
Substantially EquivalentOmega Point Systems, LLC
Clearance details
- Applicant
- Omega Point Systems, LLC
- Product code
- Code DJZ
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.