The following data is part of a premarket notification filed by Concord Laboratories, Inc. with the FDA for Pulsator Arterial Blood Sampling Syrin.
| Device ID | K833582 |
| 510k Number | K833582 |
| Device Name: | PULSATOR ARTERIAL BLOOD SAMPLING SYRIN |
| Classification | Arterial Blood Sampling Kit |
| Applicant | CONCORD LABORATORIES, 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 | 1983-10-12 |
| Decision Date | 1983-12-27 |