The following data is part of a premarket notification filed by Sechrist Industries, Inc. with the FDA for Sechrist Infant Ventrilator Model Iv-100.
Device ID | K811141 |
510k Number | K811141 |
Device Name: | SECHRIST INFANT VENTRILATOR MODEL IV-100 |
Classification | Ventilator, Continuous, Facility Use |
Applicant | SECHRIST INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CBK |
CFR Regulation Number | 868.5895 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-27 |
Decision Date | 1981-06-12 |