The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl Model 987 Electrolyte Analyzer.
| Device ID | K891578 |
| 510k Number | K891578 |
| Device Name: | AVL MODEL 987 ELECTROLYTE ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| 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 | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-20 |
| Decision Date | 1989-05-22 |