HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380— 510(k) K944301

Name: FDA 510(k) clearance K944301
Creator: U.S. Food and Drug Administration
Published: 1994-12-21

Substantially Equivalent

Hudson Respiratory Care, Inc.

FDA 510(k) clearance K944301 for HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR CATALOG NUMBERS: 5360 THROUGH 5380, Substantially Equivalent on 1994-12-21. Applicant: Hudson Respiratory Care, Inc.. Device class: 2.

Clearance details

Applicant: Hudson Respiratory Care, Inc.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1994-09-06
Decision date: 1994-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Temecula, CA, US

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.