The following data is part of a premarket notification filed by Ametek/thermox Instruments Division with the FDA for Lc Oxygen Analyzer.
Device ID | K875183 |
510k Number | K875183 |
Device Name: | LC OXYGEN ANALYZER |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | AMETEK/THERMOX INSTRUMENTS DIVISION 150 FREEPORT RD. Pittsburgh, PA 15238 |
Contact | Richard W Wanek |
Correspondent | Richard W Wanek AMETEK/THERMOX INSTRUMENTS DIVISION 150 FREEPORT RD. Pittsburgh, PA 15238 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-22 |
Decision Date | 1988-03-29 |