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510(k) K920043

AIRES by Viva-Tek Assoc., Inc. — Product Code CBN

K920043 is an FDA 510(k) premarket notification submitted by Viva-Tek Assoc., Inc. for the device "AIRES". The FDA issued a decision of Substantially Equivalent on June 16, 1993. The device falls under product code CBN (Apparatus, Gas-Scavenging), a Class II device regulated under 21 CFR 868.5430. Viva-Tek Assoc., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 1993
Date Received
January 6, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Gas-Scavenging
Device Class
Class II
Regulation Number
868.5430
Review Panel
AN
Submission Type

Other clearances by Viva-Tek Assoc., Inc.

  • K922110 — GO-CLEAN (March 9, 1994)

Other clearances for product code CBN

  • K223452 — Nitronox Scavenger Plus (March 5, 2023)
  • K193646 — Dynamic Gas Scavenging System 2 (DGSS - 2) (December 4, 2020)
  • K160950 — MINISCAV (May 5, 2017)
  • K142138 — ISO-GARD MASK (October 30, 2014)
  • K132729 — ISO-GARD MASK (January 9, 2014)
  • K123176 — ISO-GARD CLEARAIR MASK (February 14, 2013)
  • K110930 — ACTIVE WASTE GAS SCAVENGER (June 23, 2011)
  • K092031 — VAPOR-CLEAR, MODEL 100 (April 16, 2010)
  • K080039 — PASSIVE WASTE GAS SCAVENGER, MODEL 14600 (April 14, 2008)
  • K072255 — MINRAD INC. NASAL SCAVENGING CIRCUIT (October 18, 2007)

FDA data resources