The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Vasoflo-3 & Extravascular Blood Flow Probes.
Device ID | K862720 |
510k Number | K862720 |
Device Name: | VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
Contact | Robert Waxham |
Correspondent | Robert Waxham SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
Product Code | DPW |
CFR Regulation Number | 870.2100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-17 |
Decision Date | 1986-11-17 |