The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Qualistick Arterial Blood Sampler.
| Device ID | K831034 |
| 510k Number | K831034 |
| Device Name: | QUALISTICK ARTERIAL BLOOD SAMPLER |
| Classification | Arterial Blood Sampling Kit |
| Applicant | RADIOMETER AMERICA, INC. OH |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-31 |
| Decision Date | 1983-05-18 |