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510(k) K140605

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

K140605 is an FDA 510(k) premarket notification submitted by Dima Italia Srl for the device "MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC". The FDA issued a decision of Substantially Equivalent on October 3, 2014. The device falls under product code NHJ (Device, Positive Pressure Breathing, Intermittent), a Class II device regulated under 21 CFR 868.5905. Dima Italia Srl has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 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

  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 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)

Other clearances for product code NHJ

  • K253001 — KT Airway Clearance Device II (KT-3); KT Airway Clearance Device II (KT-5) (June 16, 2026)
  • K242438 — Clearo (May 16, 2025)
  • K231728 — BiWaze Clear System (April 8, 2024)
  • K213564 — BiWaze Clear System (December 21, 2022)
  • K200988 — Maximus System (May 26, 2020)
  • K191912 — BiWaze Cough (March 27, 2020)
  • K192143 — Maximus System (February 14, 2020)
  • K151689 — MetaNeb 4 System (March 17, 2016)
  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 2014)
  • K132988 — VITAL COUGH (March 28, 2014)

FDA data resources