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510(k) K915505

REGULATOR FLOWMETER by Lifeguard Medical Products, Inc. — Product Code CAN

K915505 is an FDA 510(k) premarket notification submitted by Lifeguard Medical Products, Inc. for the device "REGULATOR FLOWMETER". The FDA issued a decision of Substantially Equivalent on April 22, 1992. The device falls under product code CAN (Regulator, Pressure, Gas Cylinder), a Class I device regulated under 21 CFR 868.2700. Lifeguard Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 1992
Date Received
December 9, 1991
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 Lifeguard Medical Products, Inc.

  • K013421 — LIFEGUARD NASAL CPAP MASK AND ACCESSORIES (January 8, 2002)
  • K915296 — MONOPOLAR ELECTRODE (September 3, 1992)
  • K920471 — LEVY ARTICULATING RETRACTOR (June 23, 1992)
  • K915297 — TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM (February 11, 1992)
  • K915298 — SUCTION/IRRIGATION CANNULA; CATLOG #532.00 (January 23, 1992)
  • K880958 — LIFEGUARD BACTERIAL AND VIRAL FILTER (April 27, 1988)
  • K881087 — LIFEGUARD SINGLE USE MANUAL RESUSCITATORS (April 14, 1988)
  • K880959 — LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY (April 14, 1988)
  • K881086 — LIFEGUARD MOUTH TO MASK RESUSCITATOR (April 14, 1988)
  • K863711 — REGULATOR OXYGEN MECHANICAL (January 27, 1987)

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