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510(k) K792268

CIRCAPAK by Respiratory Care, Inc. — Product Code BZO

K792268 is an FDA 510(k) premarket notification submitted by Respiratory Care, Inc. for the device "CIRCAPAK". The FDA issued a decision of Substantially Equivalent on November 27, 1979. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Respiratory Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1979
Date Received
November 9, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
Review Panel
AN
Submission Type

Other clearances by Respiratory Care, Inc.

  • K892230 — RCI VIRAL/BACTERIAL FILTER (August 28, 1989)
  • K884150 — MODIFIED CONCHATHERM III CONTROLLED HEATER (November 21, 1988)
  • K881625 — CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL (June 21, 1988)
  • K864147 — AQUAVALVE (December 5, 1986)
  • K863955 — COLBY LEVEL ALARM (November 7, 1986)
  • K861555 — CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT (June 5, 1986)
  • K834151 — CONCHATHERM LHF HUMIDIFIER HEATER (January 13, 1984)
  • K833974 — AQUAPAK 020 HUMIDIFIER ADAPTER (December 16, 1983)
  • K832453 — SLIMB SINGLE LIMB BREATHING CIRCUIT (October 27, 1983)
  • K811524 — AQUACADE (July 1, 1981)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)

FDA data resources