RES-Q 1, 2, 3, 4 AND 5— 510(k) K881207

Name: FDA 510(k) clearance K881207
Creator: U.S. Food and Drug Administration
Published: 1988-08-15

Substantially Equivalent

Nova-Ventrx

FDA 510(k) clearance K881207 for RES-Q 1, 2, 3, 4 AND 5, Substantially Equivalent on 1988-08-15. Applicant: Nova-Ventrx. Device class: 2.

Clearance details

Applicant: Nova-Ventrx
Product code: Code BTM
Device class: Class 2
Regulation: 21 CFR 868.5915
Advisory panel: Anesthesiology
Date received: 1988-03-21
Decision date: 1988-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheeling, IL, US

Download summary PDF View on FDA.gov ↗

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K870382 — DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 30111987-03-06
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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.