The following data is part of a premarket notification filed by Uscom, Ltd. with the FDA for Uscom 1a.
| Device ID | K043139 |
| 510k Number | K043139 |
| Device Name: | USCOM 1A |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | USCOM, LTD. 1700 ROCKVILLE PIKE SUITE 400 Rockville, MD 20852 |
| Contact | Christina Kichula |
| Correspondent | Christina Kichula USCOM, LTD. 1700 ROCKVILLE PIKE SUITE 400 Rockville, MD 20852 |
| Product Code | IYN |
| Subsequent Product Code | DSB |
| Subsequent Product Code | ITX |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2005-02-15 |
| Summary: | summary |