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510(k) K832066

CONTROL 282 by Bio-Nustics, Inc. — Product Code JKS

K832066 is an FDA 510(k) premarket notification submitted by Bio-Nustics, Inc. for the device "CONTROL 282". The FDA issued a decision of Substantially Equivalent on September 29, 1983. The device falls under product code JKS (Spectral Absorb. Curve, Oxyhemoglobin, Carboxyhemoglobin, Carbon-Monoxide), a Class I device regulated under 21 CFR 862.3220.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1983
Date Received
June 27, 1983
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 for product code JKS

  • K951485 — AVOXIMETER 4000 (November 6, 1995)
  • 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)
  • K780652 — HEMOGLOBIN CHECK SOLUTIONS, S2100 OSM-2 (July 27, 1978)

FDA data resources