The following data is part of a premarket notification filed by Amedic Usa with the FDA for Ultrasound Transducer Sheaths, Sterile.
| Device ID | K871609 |
| 510k Number | K871609 |
| Device Name: | ULTRASOUND TRANSDUCER SHEATHS, STERILE |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | AMEDIC USA 3702 EAST ROESER RD, STE 27,P.O.B.62404 Phoenix, AZ 85040 -3969 |
| Contact | Jack A Moore |
| Correspondent | Jack A Moore AMEDIC USA 3702 EAST ROESER RD, STE 27,P.O.B.62404 Phoenix, AZ 85040 -3969 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-24 |
| Decision Date | 1987-07-15 |