The following data is part of a premarket notification filed by Concord/portex with the FDA for Dri-vendt/provent/accuvent Arterial Blood Gas Kits.
Device ID | K930286 |
510k Number | K930286 |
Device Name: | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS |
Classification | Arterial Blood Sampling Kit |
Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Contact | Robert Wheeler |
Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Product Code | CBT |
CFR Regulation Number | 868.1100 [🔎] |
Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-21 |
Decision Date | 1993-06-22 |