Cleared Traditional

DATEX ENGSTOM MANUAL RESUSCITATOR

K970991 · Promedic, Inc. · Anesthesiology
Jun 1997
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K970991 is an FDA 510(k) clearance for the DATEX ENGSTOM MANUAL RESUSCITATOR, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Promedic, Inc. (Mccordsville, US). The FDA issued a Cleared decision on June 16, 1997, 89 days after receiving the submission on March 19, 1997. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K970991 FDA.gov
FDA Decision Cleared SESK
Date Received March 19, 1997
Decision Date June 16, 1997
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

Similar Devices — BTM Ventilator, Emergency, Manual (resuscitator)

All 208
The BAG manual resuscitator and accessories
K251631 · Laerdal Medical AS · Nov 2025
butterflyBVM
K243861 · Compact Medical, Inc. · Apr 2025
EOlife?
K221841 · Archeon · Mar 2023
Sotair Device
K212905 · Safe Bvm Corporation · Aug 2022
Disposable Manual Resuscitator
K210288 · Xiamen Compower Medical Tech. Co., Ltd. · Aug 2021
Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20
K181583 · Flexicare Medical Limited. · Dec 2018