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510(k) K972042

PARI PEP THERAPY SYSTEM by Pari Holding Co. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1997
Date Received
June 2, 1997
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)
  • K983308 — RC CORNET, MODEL #44F50 (June 4, 1999)
  • 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)

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