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510(k) K122857

HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100 by Pegasus Research Corp. — Product Code CAF

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 7, 2012
Date Received: September 18, 2012
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nebulizer (Direct Patient Interface)
Device Class: Class II
Regulation Number: 868.5630
Review Panel: AN
Submission Type

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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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