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510(k) K962534

THERA-MIST NEBULIZER MODEL-P3000 by Pegasus Research Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1997
Date Received
June 28, 1996
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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  • 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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