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510(k) K900185

NIIC MODEL: DX901 ASPIRATION SYSTEM by Niic U.S.A., Inc. — Product Code JFL

K900185 is an FDA 510(k) premarket notification submitted by Niic U.S.A., Inc. for the device "NIIC MODEL: DX901 ASPIRATION SYSTEM". The FDA issued a decision of Substantially Equivalent on May 24, 1990. The device falls under product code JFL (Ph Rate Measurement, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Niic U.S.A., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 1990
Date Received
January 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ph Rate Measurement, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by Niic U.S.A., Inc.

  • K902133 — MODEL IS102S ND:YAG SURGICAL LASER SYSTEM (October 2, 1990)
  • K901205 — MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION) (August 14, 1990)
  • K902063 — NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM (June 29, 1990)
  • K901204 — EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS (June 5, 1990)
  • K896988 — NIIC LASER SYSTEM (January 23, 1990)
  • K895581 — MODEL: IR205 ARTICULATED SURGICAL LASER (December 13, 1989)
  • K895247 — MODEL IR103 SURGICAL LASER SYSTEM (November 16, 1989)
  • K895239 — MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER (November 16, 1989)
  • K892359 — MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM (November 16, 1989)
  • K894074 — CO2 SURGICAL LASER SYSTEM (August 24, 1989)

Other clearances for product code JFL

  • K191298 — i-STAT CHEM8+ cartridge with the i-STAT 1 System (February 7, 2020)
  • K040975 — GENCHEM CO2 ACID REAGENT (December 27, 2004)
  • K014034 — MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) (December 18, 2001)
  • K963541 — SIGMA DIAGNOSTICS CO2 ACID REAGENT (October 24, 1996)
  • K963538 — SIGMA DIAGNOSTICS CO2ALKALINE BUFFER (October 11, 1996)
  • K963540 — SIGMA DIAGNOSTICS ELECTROLYTE BUFFER (September 27, 1996)
  • K963005 — NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) (August 23, 1996)
  • K933696 — SIGMA ELECTROLYTE REFERENCE REAGENT (January 3, 1994)
  • K933691 — SIGMA CO2 ALKALINE BUFFER REAGENT (December 17, 1993)
  • K933692 — SIGMA CO2 ACID REAGENT (December 9, 1993)

FDA data resources