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510(k) K983308

RC CORNET, MODEL #44F50 by Pari Holding Co. — Product Code BWF

K983308 is an FDA 510(k) premarket notification submitted by Pari Holding Co. for the device "RC CORNET, MODEL #44F50". The FDA issued a decision of Substantially Equivalent on June 4, 1999. The device falls under product code BWF (Spirometer, Therapeutic (Incentive)), a Class II device regulated under 21 CFR 868.5690. Pari Holding Co. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1999
Date Received
September 21, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

Other clearances by Pari Holding Co.

  • K002862 — PRONEB ULTRA MODEL NUMBER 85B0100 (March 13, 2001)
  • K972042 — PARI PEP THERAPY SYSTEM (August 5, 1997)
  • K963924 — LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70 (December 10, 1996)
  • K962072 — PRONEB TURBO COMPRESSOR MODEL 38V0200 (August 21, 1996)
  • K960675 — WALKHALER PORTABLE COMPRESSOR MODEL 45F70 (May 17, 1996)
  • K935540 — PARI-MASTER MODIFICATION (March 17, 1995)
  • K944152 — PARI BABY (November 18, 1994)

Other clearances for product code BWF

  • K241152 — InSee (August 21, 2025)
  • K233855 — AllPEP (February 2, 2024)
  • K221058 — LungTrainer (MD2 & MD3) (July 5, 2023)
  • K222018 — Breathe+ (June 2, 2023)
  • K220565 — Hudson RCI Triflo II Incentive Deep Breathing Exerciser (October 25, 2022)
  • K203378 — Pulsehaler (March 31, 2021)
  • K192000 — D R Burton OxyPAP (February 19, 2020)
  • K181660 — Acapella Choice Blue Vibratory PEP Device (October 24, 2019)
  • K183108 — Combined Aerobika OPEP and VersaPAP device (August 16, 2019)
  • K182847 — Hudson RCI Voldyne Volumetric Exerciser (July 1, 2019)

FDA data resources