SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,— 510(k) K042556

Name: FDA 510(k) clearance K042556
Creator: U.S. Food and Drug Administration
Published: 2005-03-11

Substantially Equivalent

Enter Medical Corporation

FDA 510(k) clearance K042556 for SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,, Substantially Equivalent on 2005-03-11. Applicant: Enter Medical Corporation. Device class: 2.

Clearance details

Applicant: Enter Medical Corporation
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 2004-09-20
Decision date: 2005-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gui Shan Xiang,Tao Yuan Hsien, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code BTM

product code BTM

Death: 19
Other: 2
Total: 21

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.