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510(k) K936187

LSPI PRESSURE REGULATOR by Life Support Products, Inc. — Product Code CAN

K936187 is an FDA 510(k) premarket notification submitted by Life Support Products, Inc. for the device "LSPI PRESSURE REGULATOR". The FDA issued a decision of Substantially Equivalent on January 27, 1994. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Life Support Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 1994
Date Received
December 23, 1993
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 Life Support Products, Inc.

  • K941871 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000-100 (January 9, 1995)
  • K941870 — LSPI AUTOMATIC VENTILATOR, MODEL AV2000-100 (January 9, 1995)
  • K940934 — LIFE VAC (May 3, 1994)
  • K932200 — LSPI AUTOMATIC VENTILATOR (November 24, 1993)
  • K932199 — LSPI AUTOMATIC VENTILATOR, MODEL AV3000 (November 24, 1993)
  • K922819 — INFANT DISPOSABLE BAG MASK RESUSCITATOR (November 24, 1993)
  • K922691 — LSP (MODEL 554) BAG MASK RESUSCITATOR (November 24, 1993)
  • K921553 — LSPI INFANT BAG MASK (October 19, 1992)
  • K921107 — AUTOVAC (September 17, 1992)
  • K924217 — LSPI DISPOSABLE BAG MASK RESUSCITATOR/MODIFIED (September 17, 1992)

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)
  • 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)
  • K915505 — REGULATOR FLOWMETER (April 22, 1992)

FDA data resources