The following data is part of a premarket notification filed by Kronner Medical with the FDA for Blood Gas Safety Syringe.
| Device ID | K895171 |
| 510k Number | K895171 |
| Device Name: | BLOOD GAS SAFETY SYRINGE |
| Classification | Arterial Blood Sampling Kit |
| Applicant | KRONNER MEDICAL 544 WEST UMPQUA SUITE 104 Roseburg, OR 97470 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-10 |
| Decision Date | 1989-11-07 |