The following data is part of a premarket notification filed by Teledyne Brown Engineering with the FDA for Ted 191.
Device ID | K963177 |
510k Number | K963177 |
Device Name: | TED 191 |
Classification | Analyzer, Gas, Oxygen, Gaseous-phase |
Applicant | TELEDYNE BROWN ENGINEERING 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
Contact | Terry G Mahn |
Correspondent | Terry G Mahn TELEDYNE BROWN ENGINEERING 601 13TH STREET, N.W. SUITE 500 NORTH Washington, DC 20005 |
Product Code | CCL |
CFR Regulation Number | 868.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-08-14 |
Decision Date | 1997-11-13 |