The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Sonotrax Ultrasonic Fetal And Vascular Pocket Doppler, Models Lite, Basic, Pro, Ii, Ii Pro And Vascular.
Device ID | K080087 |
510k Number | K080087 |
Device Name: | SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR |
Classification | Monitor, Ultrasonic, Fetal |
Applicant | EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
Contact | William Stern |
Correspondent | William Stern EDAN INSTRUMENTS, INC. 1 ODELL PLAZA Yonkers, NY 10701 |
Product Code | KNG |
CFR Regulation Number | 884.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-11 |
Decision Date | 2008-03-11 |
Summary: | summary |