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510(k) K820091

AIRMED SMOKE EVACUATION & FILTER by James L. Geraci & Associates, Inc. — Product Code CIE

K820091 is an FDA 510(k) premarket notification submitted by James L. Geraci & Associates, Inc. for the device "AIRMED SMOKE EVACUATION & FILTER". The FDA issued a decision of Substantially Equivalent on February 24, 1982. The device falls under product code CIE (Volumetric/Manometric, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. James L. Geraci & Associates, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1982
Date Received
January 13, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Volumetric/Manometric, Carbon-Dioxide
Device Class
Class II
Regulation Number
862.1160
Review Panel
CH
Submission Type

Other clearances by James L. Geraci & Associates, Inc.

  • K853927 — LASE SYSTEM II (October 16, 1985)
  • K820079 — AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL (February 5, 1982)
  • K820078 — DRAPE, SURGICAL (February 4, 1982)
  • K811698 — CARL ZEISS INN MYRINGOTOMY TUBE LINE (August 31, 1981)

Other clearances for product code CIE

  • K904761 — P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT (November 20, 1990)
  • K880967 — MICRO CO2 APPARATUS (April 28, 1988)
  • K864313 — CO2 REAGENT SET (March 13, 1987)
  • K832071 — TOTAL CO2 REAGENT SET (August 11, 1983)
  • K800524 — SERALYZER REFLECTANCE PHOTOMETER/CALIB. (April 2, 1980)
  • K771610 — CARBON DIOXIDE ANALYZER (October 7, 1977)

FDA data resources