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 |