Last synced on 23 September 2022 at 11:05 pm

SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080087
510(k) Type
Traditional
Applicant
EDAN INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/11/2008
Days to Decision
60 days
Submission Type
Summary

SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K080087
510(k) Type
Traditional
Applicant
EDAN INSTRUMENTS, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
3/11/2008
Days to Decision
60 days
Submission Type
Summary