The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Accumeter Electronic Urinemeter System.
Device ID | K844030 |
510k Number | K844030 |
Device Name: | ACCUMETER ELECTRONIC URINEMETER SYSTEM |
Classification | Device, Urine Flow Rate Measuring, Non-electrical, Disposable |
Applicant | TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Contact | Julia A Meyer |
Correspondent | Julia A Meyer TRAVENOL LABORATORIES, S.A. Deerfield, IL 60015 |
Product Code | FFG |
CFR Regulation Number | 876.1800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-10-15 |
Decision Date | 1984-11-20 |