The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Tray, Arterial Blood Gas Sampling.
Device ID | K781857 |
510k Number | K781857 |
Device Name: | TRAY, ARTERIAL BLOOD GAS SAMPLING |
Classification | Arterial Blood Sampling Kit |
Applicant | JELCO LABORATORIES 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 | 1978-11-06 |
Decision Date | 1978-12-11 |