The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Model 912 Co-oxylite.
| Device ID | K895466 |
| 510k Number | K895466 |
| Device Name: | AVL MODEL 912 CO-OXYLITE |
| Classification | Oximeter To Measure Hemoglobin |
| Applicant | AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell, GA 30076 -4807 |
| Contact | Randy Byrd |
| Correspondent | Randy Byrd AVL SCIENTIFIC CORP. 33 MANSELL COURT Roswell, GA 30076 -4807 |
| Product Code | GLY |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-11 |
| Decision Date | 1989-11-06 |