The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Gas Sampling Lines.
Device ID | K023579 |
510k Number | K023579 |
Device Name: | GAS SAMPLING LINES |
Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
Applicant | PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Contact | Paul Dryden |
Correspondent | Paul Dryden PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville, IN 46055 -9501 |
Product Code | CCK |
CFR Regulation Number | 868.1400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-10-24 |
Decision Date | 2003-01-28 |
Summary: | summary |