Last synced on 30 September 2022 at 11:05 pm

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190353
510(k) Type
Traditional
Applicant
Residential Home Sleep Services
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/10/2020
Days to Decision
420 days
Submission Type
Summary

Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K190353
510(k) Type
Traditional
Applicant
Residential Home Sleep Services
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/10/2020
Days to Decision
420 days
Submission Type
Summary