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510(k) K951485

AVOXIMETER 4000 by A-Vox Systems, Inc. — Product Code JKS

K951485 is an FDA 510(k) premarket notification submitted by A-Vox Systems, Inc. for the device "AVOXIMETER 4000". The FDA issued a decision of Substantially Equivalent on November 6, 1995. The device falls under product code JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide), a Class I device regulated under 21 CFR 862.3220. A-Vox Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 1995
Date Received
March 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide
Device Class
Class I
Regulation Number
862.3220
Review Panel
TX
Submission Type

Other clearances by A-Vox Systems, Inc.

  • K932954 — AVOXIMETER (December 27, 1993)
  • K922075 — AVOXIMETER (November 4, 1992)

Other clearances for product code JKS

  • K863825 — CO-OXIMETER SOLUTIONS (November 24, 1986)
  • K862253 — IL 482 CO-OXIMETER (July 29, 1986)
  • K853990 — OSM3 HEMOXIMETER (December 30, 1985)
  • K833693 — TEE ADAPTER 9890-FLUSH WINDING 282 (December 30, 1983)
  • K833211 — BILE SALTS MIXTURE (October 27, 1983)
  • K832066 — CONTROL 282 (September 29, 1983)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)

FDA data resources