The following data is part of a premarket notification filed by Humanscan Company, Ltd. with the FDA for Humanscan M5s-d Ultrasound Transducer.
| Device ID | K083824 |
| 510k Number | K083824 |
| Device Name: | HUMANSCAN M5S-D ULTRASOUND TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | HUMANSCAN COMPANY, LTD. 16303 PANORMIC WAY San Leandro, CA 93478 -1116 |
| Contact | Gary Allsebrook |
| Correspondent | Gary Allsebrook HUMANSCAN COMPANY, LTD. 16303 PANORMIC WAY San Leandro, CA 93478 -1116 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-02-10 |
| Summary: | summary |