AIRES— 510(k) K920043

Substantially Equivalent

Viva-Tek Assoc., Inc.

FDA 510(k) clearance K920043 for AIRES, Substantially Equivalent on 1993-06-16. Applicant: Viva-Tek Assoc., Inc.. Device class: 2.

Clearance details

Applicant: Viva-Tek Assoc., Inc.
Product code: Code CBN
Device class: Class 2
Regulation: 21 CFR 868.5430
Advisory panel: Anesthesiology
Date received: 1992-01-06
Decision date: 1993-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medford, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CBN

K223452 — Nitronox Scavenger Plus2023-03-05
K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2)2020-12-04
K160950 — MINISCAV2017-05-05
K142138 — ISO-GARD MASK2014-10-30
K132729 — ISO-GARD MASK2014-01-09

More clearances from Viva-Tek Assoc., Inc.

K922110 — GO-CLEAN1994-03-09

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