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510(k) K072290

PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS by Dima Italia Srl — Product Code BYT

K072290 is an FDA 510(k) premarket notification submitted by Dima Italia Srl for the device "PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS". The FDA issued a decision of Substantially Equivalent on May 29, 2008. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. Dima Italia Srl has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2008
Date Received
August 16, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Device Class
Class II
Regulation Number
868.5935
Review Panel
AN
Submission Type

Other clearances by Dima Italia Srl

  • K140598 — PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC (October 16, 2014)
  • K140605 — MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC (October 3, 2014)
  • K072292 — NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS (January 7, 2008)

Other clearances for product code BYT

  • K082657 — RTX RESPIRATOR (October 8, 2008)
  • K924341 — HAYEK OSCILLATOR(TM) (July 21, 1993)
  • K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR (June 3, 1991)
  • K905530 — PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM (March 1, 1991)
  • K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (November 19, 1990)
  • K903745 — THE HAYEK OSCILLATOR (November 9, 1990)
  • K902300 — EASY BREATHER MODEL 100 ACCESSORIES (July 19, 1990)
  • K895849 — RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM (December 22, 1989)
  • K894649 — EMERSON 33-CR CHEST RESPIRATOR (October 13, 1989)
  • K893213 — EASY BREATHER MODEL 100 (August 4, 1989)

FDA data resources