The following data is part of a premarket notification filed by Sonicaid, Inc. with the FDA for Vasoscreen Impedance Plethysmograph.
Device ID | K851102 |
510k Number | K851102 |
Device Name: | VASOSCREEN IMPEDANCE PLETHYSMOGRAPH |
Classification | Phlebograph, Impedance |
Applicant | SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
Contact | Robert D Waxham |
Correspondent | Robert D Waxham SONICAID, INC. P.O. BOX 588 Fredericksburg, VA 22401 |
Product Code | DQB |
CFR Regulation Number | 870.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-19 |
Decision Date | 1985-05-16 |