The following data is part of a premarket notification filed by Lightmed Usa, Inc with the FDA for Lightmed Ultrasound System.
| Device ID | K183173 |
| 510k Number | K183173 |
| Device Name: | LIGHTMED Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Lightmed USA, Inc 1130 Calle Cordillera San Clemente, CA 92673 |
| Contact | Hedy Chiang |
| Correspondent | Hedy Chiang Lightmed USA, Inc 1130 Calle Cordillera San Clemente, CA 92673 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-16 |
| Decision Date | 2019-07-01 |