The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Biomedical Printed Silver Electrode.
Device ID | K792040 |
510k Number | K792040 |
Device Name: | BARD BIOMEDICAL PRINTED SILVER ELECTRODE |
Classification | Electrode, Electrocardiograph |
Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRX |
CFR Regulation Number | 870.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-12 |
Decision Date | 1979-11-13 |