MICRO-VENT NEBULIZER SYSTEM— 510(k) K904717

Name: FDA 510(k) clearance K904717
Creator: U.S. Food and Drug Administration
Published: 1991-04-01

Substantially Equivalent

Tri/Bor Medical, Inc.

FDA 510(k) clearance K904717 for MICRO-VENT NEBULIZER SYSTEM, Substantially Equivalent on 1991-04-01. Applicant: Tri/Bor Medical, Inc.. Device class: 2.

Clearance details

Applicant: Tri/Bor Medical, Inc.
Product code: Code CAF
Device class: Class 2
Regulation: 21 CFR 868.5630
Advisory panel: Anesthesiology
Date received: 1990-10-18
Decision date: 1991-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westtown, NY, US

Download summary PDF View on FDA.gov ↗

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More clearances from Tri/Bor Medical, Inc.

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K904718 — AERO-GEN NUBULIZER SYSTEM1991-04-01
K904715 — OXYGEN/AIR TUBING1991-01-02
K904716 — AERO-GEN NEBULIZER1991-01-02
K904719 — DISPOSABLE FACE MASK1991-01-02

Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.