STAT BLUE DISPOS. MANUAL RESUSCITATOR— 510(k) K850436

Name: FDA 510(k) clearance K850436
Creator: U.S. Food and Drug Administration
Published: 1985-02-26

Substantially Equivalent

Vital Signs, Inc.

FDA 510(k) clearance K850436 for STAT BLUE DISPOS. MANUAL RESUSCITATOR, Substantially Equivalent on 1985-02-26. Applicant: Vital Signs, Inc.. Device class: 2.

Clearance details

Applicant: Vital Signs, Inc.
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1985-02-05
Decision date: 1985-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Totowa, NJ, US

Download summary PDF View on FDA.gov ↗

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K112902 — ENFLOW IV FLUID WARMER2012-03-14
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K022402 — DISPOSABLE PRESSURE MANOMETER2002-08-22
K021315 — SURE-LOK2002-08-21

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.