The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Bv105 (&bv105r) Vascular Flow Detector W/optional.
Device ID | K873673 |
510k Number | K873673 |
Device Name: | BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL |
Classification | Probe, Blood-flow, Extravascular |
Applicant | SONICAID, INC. 11526 53RD.STREET NORTH Clearwater, FL 34620 |
Contact | Robert D Waxham |
Correspondent | Robert D Waxham SONICAID, INC. 11526 53RD.STREET NORTH Clearwater, FL 34620 |
Product Code | DPT |
CFR Regulation Number | 870.2120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-09-11 |
Decision Date | 1988-02-26 |