The following data is part of a premarket notification filed by Analytical Industries, Inc. with the FDA for Oxygen Analyzer, Models Aii 20000a, Aii 2000hc, Aii 2000m.
| Device ID | K053407 |
| 510k Number | K053407 |
| Device Name: | OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M |
| 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 | 2005-12-07 |
| Decision Date | 2006-04-05 |
| Summary: | summary |