Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac— 510(k) K190353
Substantially EquivalentResidential Home Sleep Services
FDA 510(k) clearance K190353 for Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac, Substantially Equivalent on 2020-04-10. Applicant: Residential Home Sleep Services. Device class: 2.
Clearance details
- Applicant
- Residential Home Sleep Services
- Product code
- Code PLC
- Device class
- Class 2
- Regulation
- 21 CFR 872.5570
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Battle Creek, MI, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.