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510(k) K080983

PROVENT NASAL CANNULA by Ventus Medical, Inc. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2008
Date Received
April 7, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

Other clearances by Ventus Medical, Inc.

  • K120665 — INVENT SNORING DEVICE (June 12, 2012)
  • K102404 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEE (December 2, 2010)
  • K090398 — PROVENT PROFESSIONAL SLEEP APNEA THERAPY (April 3, 2009)
  • K071560 — PROVENT NASAL DILATOR, MODEL BR2 (February 8, 2008)

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