The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Urine Meter W/ Bag.
Device ID | K761083 |
510k Number | K761083 |
Device Name: | BARD URINE METER W/ BAG |
Classification | Urinometer, Mechanical |
Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | EXR |
CFR Regulation Number | 876.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-11-19 |
Decision Date | 1977-01-26 |