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 |