The following data is part of a premarket notification filed by Chesebrough-pond's U.s.a. Co. with the FDA for Marz-175 Arterial Blood Gas Syringe.
Device ID | K833923 |
510k Number | K833923 |
Device Name: | MARZ-175 ARTERIAL BLOOD GAS SYRINGE |
Classification | Arterial Blood Sampling Kit |
Applicant | CHESEBROUGH-POND'S U.S.A. CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBT |
CFR Regulation Number | 868.1100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-11-14 |
Decision Date | 1984-01-09 |