The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Adr 3160 W/probes Plb-308m, Plb-508m, & Plb-310m.
| Device ID | K852947 |
| 510k Number | K852947 |
| Device Name: | ADR 3160 W/PROBES PLB-308M, PLB-508M, & PLB-310M |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | John Dellinger |
| Correspondent | John Dellinger ADVANCED TECHNOLOGY LABORATORIES, INC. 22100 BOTHELL EVERETT HWY. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-11 |
| Decision Date | 1986-01-06 |