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SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160343
510(k) Type
Traditional
Applicant
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/7/2016
Days to Decision
59 days
Submission Type
Summary

SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K160343
510(k) Type
Traditional
Applicant
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/7/2016
Days to Decision
59 days
Submission Type
Summary