The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sechrist Volume Ventilator Model 2200b.
Device ID | K896269 |
510k Number | K896269 |
Device Name: | SECHRIST VOLUME VENTILATOR MODEL 2200B |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
Contact | Sandra L Davis |
Correspondent | Sandra L Davis SECHRIST INDUSTRIES, INC. 2820 GRETTA LN. Anaheim, CA 92806 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-31 |
Decision Date | 1990-05-18 |