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510(k) K091111

RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC by Instrumentation Industries, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2009
Date Received
April 17, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

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  • K081778 — NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS (September 12, 2008)
  • K081693 — NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS (September 11, 2008)
  • 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)

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