The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Electrode A.ph Blood Gas B.electrolyte Systems.
| Device ID | K884267 |
| 510k Number | K884267 |
| Device Name: | ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Contact | Alexander J Kovacs |
| Correspondent | Alexander J Kovacs ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-11 |
| Decision Date | 1989-05-04 |