The following data is part of a premarket notification filed by Nihon Kohden America, Inc. with the FDA for Ag-839pa Co2 Module And Accessories.
Device ID | K944027 |
510k Number | K944027 |
Device Name: | AG-839PA CO2 MODULE AND ACCESSORIES |
Classification | Transducer, Gas Pressure |
Applicant | NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
Contact | Penni Pannell |
Correspondent | Penni Pannell NIHON KOHDEN AMERICA, INC. 2601 CAMPUS DR. Irvine, CA 92612 -1601 |
Product Code | BXO |
CFR Regulation Number | 868.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-17 |
Decision Date | 1994-08-31 |