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510(k) K102127

ENDOTRACHEAL TUBE CHANGERS by Instrumentation Industries, Inc. — Product Code LNZ

K102127 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "ENDOTRACHEAL TUBE CHANGERS". The FDA issued a decision of Substantially Equivalent on August 27, 2010. The device falls under product code LNZ (Changer, Tube, Endotracheal), a Class II device regulated under 21 CFR 868.5730. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2010
Date Received
July 29, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Changer, Tube, Endotracheal
Device Class
Class II
Regulation Number
868.5730
Review Panel
AN
Submission Type

Other clearances by Instrumentation Industries, Inc.

  • K180510 — NS 120P-TRS Airway Pressure Gauge (May 1, 2019)
  • K162753 — RTC 26-C Inline Aerosol Adapter (February 28, 2017)
  • K113644 — PILOT TUBE REPAIR KIT (January 26, 2012)
  • K101857 — RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V (July 22, 2010)
  • K091111 — RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI AD (December 2, 2009)
  • 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)

FDA data resources