TRACH-ASSIST— 510(k) K083702

Substantially Equivalent

Mergenet Medical

FDA 510(k) clearance K083702 for TRACH-ASSIST, Substantially Equivalent on 2009-03-05. Applicant: Mergenet Medical. Device class: 1.

Clearance details

Applicant: Mergenet Medical
Product code: Code BZA
Device class: Class 1
Regulation: 21 CFR 868.5810
Advisory panel: Anesthesiology
Date received: 2008-12-15
Decision date: 2009-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZA

K954383 — SURELOC CIRCUIT CONNECTOR1995-12-22
K954197 — DISPOSABLE FLEX TUBE1995-10-26
K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS1995-09-19
K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR1995-07-20
K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING1995-04-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.