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510(k) K770632

GAS COLLHCTOR BE 155(155-2-3,154-4) by Instrumentation Industries, Inc. — Product Code KGK

K770632 is an FDA 510(k) premarket notification submitted by Instrumentation Industries, Inc. for the device "GAS COLLHCTOR BE 155(155-2-3,154-4)". The FDA issued a decision of Substantially Equivalent on April 8, 1977. The device falls under product code KGK (Gas, Collecting Vessel), a Class I device regulated under 21 CFR 868.1575. Instrumentation Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1977
Date Received
April 4, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas, Collecting Vessel
Device Class
Class I
Regulation Number
868.1575
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)
  • K102127 — ENDOTRACHEAL TUBE CHANGERS (August 27, 2010)
  • 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)

Other clearances for product code KGK

  • K863171 — RESPIRONICS PROTECTEASY (October 15, 1986)

FDA data resources