CARDIOPULMUNARY RESUSCITATOR— 510(k) K811909

Name: FDA 510(k) clearance K811909
Creator: U.S. Food and Drug Administration
Published: 1981-07-16

Substantially Equivalent

Michigan Instruments, Inc.

FDA 510(k) clearance K811909 for CARDIOPULMUNARY RESUSCITATOR, Substantially Equivalent on 1981-07-16. Applicant: Michigan Instruments, Inc.. Device class: 2.

Clearance details

Applicant: Michigan Instruments, Inc.
Product code: Code DRM
Device class: Class 2
Regulation: 21 CFR 870.5200
Advisory panel: Cardiovascular
Date received: 1981-07-01
Decision date: 1981-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K161768 — LUCAS 3 Chest Compression System2016-11-09
K153628 — ROSC-U Mini Chest Compressor (RMCC)2016-01-30

More clearances from Michigan Instruments, Inc.

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K073079 — THUMPER, MODEL: 10082008-02-14
K972525 — THUMPER1997-10-02
K962237 — THUMPER CARDIOPULMONARY RESUSCITATOR1996-09-05
K895954 — LARYNGOSTAT LARYNGOSCOPE HANDLE1989-10-30
K851139 — THUMPER CARDIOPULMONARY RESUSCITATOR 10051985-05-15

Adverse events under product code DRM

product code DRM

Death: 82
Injury: 126
Malfunction: 4,539
Total: 4,747

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.