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510(k) K880959

LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY by Lifeguard Medical Products, Inc. — Product Code BZO

K880959 is an FDA 510(k) premarket notification submitted by Lifeguard Medical Products, Inc. for the device "LIFEGUARD GAS SAMPLING LINE FOR MASS SPECTROMETRY". The FDA issued a decision of Substantially Equivalent on April 14, 1988. The device falls under product code BZO (Set, Tubing And Support, Ventilator (W Harness)), a Class I device regulated under 21 CFR 868.5975. Lifeguard Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1988
Date Received
March 7, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Tubing And Support, Ventilator (W Harness)
Device Class
Class I
Regulation Number
868.5975
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)
  • K881087 — LIFEGUARD SINGLE USE MANUAL RESUSCITATORS (April 14, 1988)
  • K881086 — LIFEGUARD MOUTH TO MASK RESUSCITATOR (April 14, 1988)
  • K863711 — REGULATOR OXYGEN MECHANICAL (January 27, 1987)

Other clearances for product code BZO

  • K953784 — UNICOR, INC. CORRUGATED TUBING (September 19, 1995)
  • K953785 — UNICOR, INC. VENTILATOR HOSES (September 18, 1995)
  • K952011 — PRIMA BREATHING BAGS (May 22, 1995)
  • K952022 — PRIMA VOLUMN VENTILATORSS (May 22, 1995)
  • K952010 — PRIMA VENTILATOR HOSES (May 22, 1995)
  • K952012 — PRIMA CUSTOM ANESTESIA CIRCUIT (May 22, 1995)
  • K945740 — INFANT FLOW SYSTEM (March 23, 1995)
  • K944531 — PRIMA, INC. CORRUGATED TUBING (December 2, 1994)
  • K942572 — VOLUME VENTILATOR (June 10, 1994)
  • K942569 — VENTILATOR HOSE (June 10, 1994)

FDA data resources