Last synced on 14 June 2024 at 11:05 pm

Eclipse II with Smart Noise Cancellation

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213307
510(k) Type
Traditional
Applicant
Carestream Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/14/2022
Days to Decision
102 days
Submission Type
Summary

Eclipse II with Smart Noise Cancellation

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K213307
510(k) Type
Traditional
Applicant
Carestream Health, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/14/2022
Days to Decision
102 days
Submission Type
Summary