The following data is part of a premarket notification filed by Advanced Diagnostic Medical Systems, Inc. with the FDA for Probe Sheath For Adms Ultrasound Probe.
| Device ID | K881208 |
| 510k Number | K881208 |
| Device Name: | PROBE SHEATH FOR ADMS ULTRASOUND PROBE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. 6905 SIERRA COURT Dublin, CA 94568 |
| Contact | J Allsebrook |
| Correspondent | J Allsebrook ADVANCED DIAGNOSTIC MEDICAL SYSTEMS, INC. 6905 SIERRA COURT Dublin, CA 94568 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-21 |
| Decision Date | 1988-05-16 |