The following data is part of a premarket notification filed by Teledyne Analytical Instruments with the FDA for Mx 300 Oxygen Monitor.
Device ID | K024155 |
510k Number | K024155 |
Device Name: | MX 300 OXYGEN MONITOR |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | TELEDYNE ANALYTICAL INSTRUMENTS 16830 CHESTNUT ST. City Of Industry, CA 91749 |
Contact | Ray Khajavi |
Correspondent | Ray Khajavi TELEDYNE ANALYTICAL INSTRUMENTS 16830 CHESTNUT ST. City Of Industry, CA 91749 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-17 |
Decision Date | 2003-07-17 |