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- Subpart B—Diagnostic DevicesCFR Sub-Part
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The Luco Hybrid OSA Appliance
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K160477
- 510(k) Type
- Traditional
- Applicant
- LUCO HYBRID OSA APPLIANCE INC.
- Country
- Canada
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/29/2016
- Days to Decision
- 161 days
- Submission Type
- Statement