The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sehrist Volume Ventilator, Model 2200b.
Device ID | K914607 |
510k Number | K914607 |
Device Name: | SEHRIST VOLUME VENTILATOR, MODEL 2200B |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Contact | Thomas R Meyers |
Correspondent | Thomas R Meyers SECHRIST INDUSTRIES, INC. 4225 EAST LA PALMA Anaheim, CA 92807 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-10-17 |
Decision Date | 1992-11-02 |