The following data is part of a premarket notification filed by R4 Telemedicine, Inc. with the FDA for Remote Fetal Medicine Ultrasound System.
| Device ID | K000443 |
| 510k Number | K000443 |
| Device Name: | REMOTE FETAL MEDICINE ULTRASOUND SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | R4 TELEMEDICINE, INC. 1301 K ST. N.W. SUITE 800 EAST Washington, DC 20005 -3333 |
| Contact | Thomas B Smith |
| Correspondent | Thomas B Smith R4 TELEMEDICINE, INC. 1301 K ST. N.W. SUITE 800 EAST Washington, DC 20005 -3333 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-10 |
| Decision Date | 2000-04-24 |