The following data is part of a premarket notification filed by Avl Scientific Corp. with the FDA for Avl 9110ph Analyzer.
Device ID | K932642 |
510k Number | K932642 |
Device Name: | AVL 9110PH 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 | 1993-06-02 |
Decision Date | 1993-10-14 |