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510(k) K081693

NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS by Instrumentation Industries, Inc. — Product Code BXR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2008
Date Received
June 17, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Airway Pressure (Inspiratory Force)
Device Class
Class II
Regulation Number
868.1780
Review Panel
AN
Submission Type

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  • K991355 — METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE (January 27, 2000)
  • K992670 — OXYGEN ENRICHMENT KIT, MODELS SG 066, SG 067 (September 17, 1999)
  • K991785 — MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT (August 17, 1999)

Other clearances for product code BXR

  • K032593 — MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETER (February 3, 2004)
  • K912946 — COLLINS DIGITAL PULMONARY MANOMETER (January 15, 1992)
  • K904917 — THAYER MIP ADAPTER (January 28, 1991)
  • K901998 — DIGITAL MANOMETER (DM 50) (July 25, 1990)
  • K873498 — INSPIRATORY FORCE MONT KIT/MANIFOLD/METER/TUBING (March 9, 1988)