The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for Scanheads-access 10pv, Biostatic.
| Device ID | K843620 |
| 510k Number | K843620 |
| Device Name: | SCANHEADS-ACCESS 10PV, BIOSTATIC |
| Classification | Transducer, Ultrasonic |
| Applicant | ADVANCED TECHNOLOGY LABORATORIES, INC. P.O. BOX 6639 Bellevue, WA 98008 |
| Contact | Francis G Smith |
| Correspondent | Francis G Smith ADVANCED TECHNOLOGY LABORATORIES, INC. P.O. BOX 6639 Bellevue, WA 98008 |
| Product Code | JOP |
| CFR Regulation Number | 870.2880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-14 |
| Decision Date | 1985-03-12 |