The following data is part of a premarket notification filed by Analytical Industries, Inc. with the FDA for 'all 2000' % Oxygen Analyzer.
Device ID | K002382 |
510k Number | K002382 |
Device Name: | 'ALL 2000' % OXYGEN ANALYZER |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | ANALYTICAL INDUSTRIES, INC. 2855 METROPOLITAN PL. Pomona, CA 91767 |
Contact | Patrick J Prindible |
Correspondent | Patrick J Prindible ANALYTICAL INDUSTRIES, INC. 2855 METROPOLITAN PL. Pomona, CA 91767 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-08-04 |
Decision Date | 2001-03-14 |