The following data is part of a premarket notification filed by Bioelectrical Sciences, Inc. with the FDA for Biological Ohm Meter, Bes 200z.
Device ID | K880926 |
510k Number | K880926 |
Device Name: | BIOLOGICAL OHM METER, BES 200Z |
Classification | Plethysmograph, Impedance |
Applicant | BIOELECTRICAL SCIENCES, INC. 5580 LA JOLLA BLVD. SUITE 417 La Jolla, CA 92037 |
Contact | Glassford |
Correspondent | Glassford BIOELECTRICAL SCIENCES, INC. 5580 LA JOLLA BLVD. SUITE 417 La Jolla, CA 92037 |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-03-04 |
Decision Date | 1988-06-15 |