SLEEP STUDY ANALYSIS (SSA) VERSION 96.10— 510(k) K963631
Substantially EquivalentOmega Results
FDA 510(k) clearance K963631 for SLEEP STUDY ANALYSIS (SSA) VERSION 96.10, Substantially Equivalent on 1997-04-02. Applicant: Omega Results. Device class: 2.
Clearance details
- Applicant
- Omega Results
- Product code
- Code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code OLZ
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