OXYGEN POWERED RESUSCITATOR FOR CPR— 510(k) K920910

Name: FDA 510(k) clearance K920910
Creator: U.S. Food and Drug Administration
Published: 1993-01-12

Substantially Equivalent

J. H. Emerson Co.

FDA 510(k) clearance K920910 for OXYGEN POWERED RESUSCITATOR FOR CPR, Substantially Equivalent on 1993-01-12. Applicant: J. H. Emerson Co.. Device class: 2.

Clearance details

Applicant: J. H. Emerson Co.
Product code: Code BTL
Device class: Class 2
Regulation: 21 CFR 868.5925
Advisory panel: Anesthesiology
Date received: 1992-02-27
Decision date: 1993-01-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTL

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K221634 — Oxymag - Transport and Emergency Ventilator2023-05-24
K202219 — VORTRAN GO2VENT with PEEP Valve2021-02-11
K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag2020-11-20
K182956 — Puffin Lite Infant Resuscitation System2019-01-18

More clearances from J. H. Emerson Co.

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K002598 — EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING2000-11-22
K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA1992-11-17
K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM1990-11-19
K896721 — MODEL 7-AT TREATMENT CHAMBER1990-01-22
K881808 — EMERSON CHEST RESPIRATOR, MODEL 33-CRE1988-08-04

Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.