The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Model 945 Blood Gas System.
| Device ID | K834601 |
| 510k Number | K834601 |
| Device Name: | AVL MODEL 945 BLOOD GAS SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | AVL SCIENTIFIC CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-30 |
| Decision Date | 1984-03-09 |