The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sechrist Series 3500 Air-oxygen Mixer.
Device ID | K802226 |
510k Number | K802226 |
Device Name: | SECHRIST SERIES 3500 AIR-OXYGEN MIXER |
Classification | Mixer, Breathing Gases, Anesthesia Inhalation |
Applicant | SECHRIST INDUSTRIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BZR |
CFR Regulation Number | 868.5330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-12 |
Decision Date | 1980-09-26 |