The following data is part of a premarket notification filed by Respiratory Care, Inc. with the FDA for Arterial Blood Sampling Tray.
Device ID | K771975 |
510k Number | K771975 |
Device Name: | ARTERIAL BLOOD SAMPLING TRAY |
Classification | Arterial Blood Sampling Kit |
Applicant | RESPIRATORY CARE, INC. 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 | 1977-10-17 |
Decision Date | 1977-10-28 |