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510(k) K914416

BREATH-EASY, MODIFICATION by Icor AB — Product Code HME

K914416 is an FDA 510(k) premarket notification submitted by Icor AB for the device "BREATH-EASY, MODIFICATION". The FDA issued a decision of Substantially Equivalent on June 23, 1992. The device falls under product code HME (Chair, Ophthalmic, Ac-Powered), a Class I device regulated under 21 CFR 886.1140. Icor AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1992
Date Received
September 25, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chair, Ophthalmic, Ac-Powered
Device Class
Class I
Regulation Number
886.1140
Review Panel
OP
Submission Type

Other clearances by Icor AB

  • K954402 — ET-TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (May 22, 1996)
  • K953507 — TYPE 1 & 2 (HUMIDAIR I & II) (September 7, 1995)
  • K952325 — ET TUBE PLACEMENT DETECTOR (WITH COLIBRI INDICATOR) (July 31, 1995)
  • K952823 — FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXR (July 13, 1995)
  • K941987 — HEAT AND MOISTURE EXCHANGERS AND FILTERS (August 15, 1994)
  • K940041 — COLIBRI (July 27, 1994)
  • K941436 — AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF (June 8, 1994)
  • K925622 — FHB, FHB-T, FHBFLEX, FHBFLEX-T (May 26, 1993)
  • K904338 — ICOR HCH 4, ICOR HCH 7 (December 4, 1990)
  • K900150 — HCH 9165, 9165 S, 9166, HFH, HFH-T HEAT MOISTURE (January 25, 1990)

Other clearances for product code HME

  • K930449 — MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR (July 6, 1993)
  • K894018 — RELIANCE(R) 6200 EXAMINATION CHAIR (September 12, 1989)
  • K870112 — STORZ ENT/OPHTHALMIC MAXI CHAIR (February 12, 1987)
  • K864494 — MODEL 6500 OPTHALMIC CHAIR (December 15, 1986)
  • K864574 — MAC 150E OPTHALMIC CHAIR (December 15, 1986)
  • K863728 — THE ERGOSYSTEM CHAIR (October 31, 1986)
  • K863008 — -OM WEST 2000 GNATUS CHAIR (September 24, 1986)
  • K853743 — TECHNA VISION, INC. ELECTRIC CHAIR (October 17, 1985)
  • K853149 — RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 (September 5, 1985)
  • K853150 — RELIANCE 6100 (September 5, 1985)

FDA data resources