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510(k) K811162

FLOWLOCK OXYGEN METER by Lifeguard Medical Products, Inc. — Product Code BYJ

K811162 is an FDA 510(k) premarket notification submitted by Lifeguard Medical Products, Inc. for the device "FLOWLOCK OXYGEN METER". The FDA issued a decision of Substantially Equivalent on May 8, 1981. The device falls under product code BYJ (Unit, Liquid-Oxygen, Portable), a Class II device regulated under 21 CFR 868.5655. Lifeguard Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1981
Date Received
April 28, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Liquid-Oxygen, Portable
Device Class
Class II
Regulation Number
868.5655
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)
  • K915505 — REGULATOR FLOWMETER (April 22, 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)
  • K880959 — LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY (April 14, 1988)
  • K881087 — LIFEGUARD SINGLE USE MANUAL RESUSCITATORS (April 14, 1988)
  • K881086 — LIFEGUARD MOUTH TO MASK RESUSCITATOR (April 14, 1988)

Other clearances for product code BYJ

  • K130068 — DISMOUNTED MEDICAL & SUPPLEMENTAL OXYGEN SYSTEM (DMOS) (July 19, 2013)
  • K113767 — MOUNTED MEDICAL OXYGEN SYSTEM (June 29, 2012)
  • K103324 — PRECISION LIQUID OXYGEN SYSTEM (April 21, 2011)
  • K101272 — MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3 (August 20, 2010)
  • K081779 — GOLOX-93 (September 19, 2008)
  • K080023 — MODIFICATION TO: SPIRIT (June 16, 2008)
  • K072723 — RESPIRONICS GOLOX (March 20, 2008)
  • K072011 — COPD LIQUID OXYGEN PORTABLE, MODEL 300P (October 18, 2007)
  • K071581 — BACKPACK MEDICAL OXYGEN SYSTEM (July 11, 2007)
  • K050153 — SPIRIT, MODEL HAS (April 15, 2005)

FDA data resources