The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Ultrasonic Tabletop Doppler, Models Sd5 And Sd6.
| Device ID | K092997 |
| 510k Number | K092997 |
| Device Name: | ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 |
| 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 | 2009-09-28 |
| Decision Date | 2009-11-10 |
| Summary: | summary |