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510(k) K952012

PRIMA CUSTOM ANESTESIA CIRCUIT by Prima, Inc. — Product Code BZO

K952012 is an FDA 510(k) premarket notification submitted by Prima, Inc. for the device "PRIMA CUSTOM ANESTESIA CIRCUIT". The FDA issued a decision of Substantially Equivalent on May 22, 1995. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Prima, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1995
Date Received
April 28, 1995
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 Prima, Inc.

  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952013 — PRIMA GUEDEL AIRWAYS (May 22, 1995)
  • K952019 — PRIMA ADULT GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952015 — PRIMA FILTER (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K935582 — TUBE, INHALER OXYGEN (January 14, 1994)

FDA data resources