SAVE MOR— 510(k) K801945

Name: FDA 510(k) clearance K801945
Creator: U.S. Food and Drug Administration
Published: 1980-11-19

Substantially Equivalent

Cardia Concepts Corp.

FDA 510(k) clearance K801945 for SAVE MOR, Substantially Equivalent on 1980-11-19. Applicant: Cardia Concepts Corp.. Device class: 2.

Clearance details

Applicant: Cardia Concepts Corp.
Product code: Code DRM
Device class: Class 2
Regulation: 21 CFR 870.5200
Advisory panel: Cardiovascular
Date received: 1980-08-14
Decision date: 1980-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K173553 — LUCAS 3 Chest Compression System2018-02-08
K161768 — LUCAS 3 Chest Compression System2016-11-09
K153628 — ROSC-U Mini Chest Compressor (RMCC)2016-01-30

More clearances from Cardia Concepts Corp.

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K801946 — CPR HELPER1980-11-19
K801947 — CPR TRAVELER1980-11-19

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.