The following data is part of a premarket notification filed by Elcat, Gmbh with the FDA for Handydop.
| Device ID | K030466 |
| 510k Number | K030466 |
| Device Name: | HANDYDOP |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | ELCAT, GMBH 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour ELCAT, GMBH 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-12 |
| Decision Date | 2003-09-12 |
| Summary: | summary |