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510(k) K140598

PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC by Dima Italia Srl — Product Code NHJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2014
Date Received
March 10, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Positive Pressure Breathing, Intermittent
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Dima Italia Srl

  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
  • K072290 — PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS (May 29, 2008)
  • K072292 — NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS (January 7, 2008)

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  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
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