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510(k) K810132

MODEL 2 FLOWMETER by Harris Calorific — Product Code CAN

K810132 is an FDA 510(k) premarket notification submitted by Harris Calorific for the device "MODEL 2 FLOWMETER". The FDA issued a decision of Substantially Equivalent on January 28, 1981. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Harris Calorific has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1981
Date Received
January 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Pressure, Gas Cylinder
Device Class
Class I
Regulation Number
868.2700
Review Panel
AN
Submission Type

Other clearances by Harris Calorific

  • K791648 — MODEL 54 FLOWMETER BACK-PRESSURE TUBE (September 17, 1979)

Other clearances for product code CAN

  • K162811 — MR Conditional CGA 870 (March 2, 2017)
  • K080243 — PORTABLE OXYGEN UNIT SCA900 (April 7, 2009)
  • K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (October 25, 2006)
  • K061785 — CYL-FIL OXYGEN SYSTEM (September 7, 2006)
  • K950777 — OXYGEN REGULATOR (April 14, 1995)
  • K942751 — VANGUARD SERIES GAS REGULATORS (February 9, 1995)
  • K936187 — LSPI PRESSURE REGULATOR (January 27, 1994)
  • K932006 — 1500 SERIES REGULATOR (October 25, 1993)
  • K921125 — AMBU OXYGEN REGULATOR (September 17, 1992)
  • K915154 — GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (May 27, 1992)

FDA data resources