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510(k) K952015

PRIMA FILTER by Prima, Inc. — Product Code CAH

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
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Prima, Inc.

  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K952021 — PRIMA HYUPERINFLATION SYSTEM (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952020 — PRIMA PEDIATRIC ANESTHESIA CIRCUITS (May 22, 1995)
  • K952017 — PRIMA MAPLESON D CIRCUIT (May 22, 1995)
  • K952013 — PRIMA GUEDEL AIRWAYS (May 22, 1995)
  • K952016 — PRIMA PEDIATRIC GAS SAMPLING CIRCUITS (May 22, 1995)
  • K952018 — PRIMA COAXIAL CIRCUITS (May 22, 1995)
  • K952014 — PRIMA ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS (May 22, 1995)

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  • K210352 — GGM Breathing Circuit Bacterial Filter (March 27, 2022)
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