The following data is part of a premarket notification filed by Advanced Technology Laboratories, Inc. with the FDA for High Freq Linear Array(hfla)scanhead W/dplr Sidear.
Device ID | K872441 |
510k Number | K872441 |
Device Name: | HIGH FREQ LINEAR ARRAY(HFLA)SCANHEAD W/DPLR SIDEAR |
Classification | Probe, Blood-flow, Extravascular |
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 | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-19 |
Decision Date | 1988-02-19 |