Last synced on 24 June 2022 at 11:05 pm

Peak.me

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180487
510(k) Type
Traditional
Applicant
Breathe me LTD
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
10/26/2018
Days to Decision
245 days
Submission Type
Summary

Peak.me

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K180487
510(k) Type
Traditional
Applicant
Breathe me LTD
Country
Israel
FDA Decision
Substantially Equivalent
Decision Date
10/26/2018
Days to Decision
245 days
Submission Type
Summary