The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Opti R Analyzer.
| Device ID | K000103 |
| 510k Number | K000103 |
| Device Name: | AVL OPTI R ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | AVL SCIENTIFIC CORP. 235 HEMBREE PARK DR. Roswell, GA 30076 |
| Contact | Randy Byrd |
| Correspondent | Randy Byrd AVL SCIENTIFIC CORP. 235 HEMBREE PARK DR. Roswell, GA 30076 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-13 |
| Decision Date | 2000-03-20 |