Last synced on 24 May 2024 at 11:04 pm

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232653
510(k) Type
Traditional
Applicant
Blue Sky Bio, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/3/2024
Days to Decision
216 days
Submission Type
Summary

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K232653
510(k) Type
Traditional
Applicant
Blue Sky Bio, LLC
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/3/2024
Days to Decision
216 days
Submission Type
Summary