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510(k) K984468

VITAL PEP by Vital Signs, Inc. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1999
Date Received
December 16, 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 Vital Signs, Inc.

  • K112902 — ENFLOW IV FLUID WARMER (March 14, 2012)
  • K041309 — IMASK TM (June 30, 2004)
  • K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (October 15, 2003)
  • K022402 — DISPOSABLE PRESSURE MANOMETER (August 22, 2002)
  • K021315 — SURE-LOK (August 21, 2002)
  • K002454 — BREAS HA50 HUMIDIFIER, MODEL HA50 (March 7, 2001)
  • K001553 — BREAS PV 100 CPAP SYSTEM (August 3, 2000)
  • K000441 — BODYGUARD (April 11, 2000)
  • K994044 — CLEEN-ABLE (February 25, 2000)
  • K990412 — CUFF-ABLE PLUS (September 1, 1999)

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)