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510(k) K880473

AERO-MIST NEBULIZER HEATER by Pegasus Research Corp. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1988
Date Received
February 4, 1988
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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  • K903489 — THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000 (December 10, 1990)
  • K893942 — THERA-MIST(TM) NEBULIZER, MODEL 30000 (August 28, 1989)

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