The following data is part of a premarket notification filed by D. E. Hokanson, Inc. with the FDA for P-2 Ultrasonic Arteriograph.
Device ID | K792015 |
510k Number | K792015 |
Device Name: | P-2 ULTRASONIC ARTERIOGRAPH |
Classification | Probe, Blood-flow, Extravascular |
Applicant | D. E. HOKANSON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-05 |
Decision Date | 1979-12-04 |