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510(k) K013421

LIFEGUARD NASAL CPAP MASK AND ACCESSORIES by Lifeguard Medical Products, Inc. — Product Code BZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2002
Date Received
October 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Non-Continuous (Respirator)
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances by Lifeguard Medical Products, Inc.

  • 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)
  • K881087 — LIFEGUARD SINGLE USE MANUAL RESUSCITATORS (April 14, 1988)
  • K881086 — LIFEGUARD MOUTH TO MASK RESUSCITATOR (April 14, 1988)
  • K880959 — LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY (April 14, 1988)
  • K863711 — REGULATOR OXYGEN MECHANICAL (January 27, 1987)

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