The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sechrist Air/oxygen Mixer, Model 3500 Cp-g.
| Device ID | K023745 |
| 510k Number | K023745 |
| Device Name: | SECHRIST AIR/OXYGEN MIXER, MODEL 3500 CP-G |
| Classification | Gas Control Unit, Cardiopulmonary Bypass |
| Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
| Contact | Greg Godfrey |
| Correspondent | Greg Godfrey SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
| Product Code | DTX |
| CFR Regulation Number | 870.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-07 |
| Decision Date | 2003-01-17 |
| Summary: | summary |