The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Qs90 Smooth E Arterial Blood Sampler.
| Device ID | K896514 |
| 510k Number | K896514 |
| Device Name: | QS90 SMOOTH E ARTERIAL BLOOD SAMPLER |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Contact | Donald L Baker |
| Correspondent | Donald L Baker RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-14 |
| Decision Date | 1990-01-23 |