BREATHKEY MODEL G10/BREATHKEY MODEL G30X— 510(k) K052804
Substantially EquivalentOmega Point Systems, LLC
FDA 510(k) clearance K052804 for BREATHKEY MODEL G10/BREATHKEY MODEL G30X, Substantially Equivalent on 2005-12-09. Applicant: Omega Point Systems, LLC. Device class: 1.
Clearance details
- Applicant
- Omega Point Systems, LLC
- Product code
- Code DJZ
- Device class
- Class 1
- Regulation
- 21 CFR 862.3050
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cincinnati, OH, US
Recent devices under product code DJZ
view allData sourced from openFDA. This site is unofficial and independent of the FDA.