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510(k) K020700

PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY by Pegasus Research Corp. — Product Code BTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2004
Date Received
March 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Humidifier, Respiratory Gas, (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5450
Review Panel
AN
Submission Type

Other clearances by Pegasus Research Corp.

  • K122857 — HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, (November 7, 2012)
  • K013856 — PMH 1000 HEATED HUMIDIFIER (February 21, 2003)
  • K983783 — HEATED HUMIDIFIER (October 24, 2000)
  • K962534 — THERA-MIST NEBULIZER MODEL-P3000 (February 28, 1997)
  • K946057 — AQUALARM MOISTURE SENSOR MODEL P85000 (May 5, 1995)
  • K915890 — AUTOCLAVABLE THERA-MIST HUMIDIFIER P3600, MODIFIED (June 24, 1992)
  • K914465 — AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000 (March 31, 1992)
  • K903489 — THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 (December 10, 1990)
  • K893942 — THERA-MIST(TM) NEBULIZER, MODEL 30000 (August 28, 1989)
  • K894000 — THERA-MIST HUMIDIFIER (August 28, 1989)

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