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510(k) K874513

MONAGHAN AEROCHAMBER WITH MASK by Monaghan Medical Corp. — Product Code CCQ

K874513 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corp. for the device "MONAGHAN AEROCHAMBER WITH MASK". The FDA issued a decision of Substantially Equivalent on December 30, 1987. The device falls under product code CCQ (Nebulizer, Medicinal, Non-Ventilatory (Atomizer)), a Class I device regulated under 21 CFR 868.5640. Monaghan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
November 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Device Class
Class I
Regulation Number
868.5640
Review Panel
AN
Submission Type

Other clearances by Monaghan Medical Corp.

  • K123945 — STRIVE DUAL ZONE PEAK FLOW METER (April 17, 2013)
  • K031514 — MODIFICATION TO TRUPEAK PEAK FLOW METER (May 23, 2003)
  • K023097 — TRUEZONE PEAK FLOW METER (March 7, 2003)
  • K012939 — AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER (September 28, 2001)
  • K991212 — MODIFICATION TO TRUZONE PEAK FLOW METER (July 1, 1999)
  • K964130 — AEROGEAR ASTHMA ACTION KIT (January 10, 1997)
  • K963089 — TRUZONE PEAK FLOW METER (November 6, 1996)
  • K963095 — TRUPEAK PEAK FLOW METER (November 4, 1996)
  • K955234 — TRUPEAK PEAK FLOW METER (March 18, 1996)
  • K955262 — TRUZONE PEAK FLOW METER (March 7, 1996)

Other clearances for product code CCQ

  • K972397 — EZ SPRAY (September 23, 1997)
  • K964956 — E-Z SPACER MASK (SMALL) (April 23, 1997)
  • K961894 — MDI TUTOR (August 14, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K960593 — SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIR (May 10, 1996)
  • K922033 — SALINE SOLUTION- STERILE (July 21, 1992)
  • K900576 — MODIFIED AEROCHAMBER WITH MASK (May 13, 1991)
  • K900557 — MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER (April 10, 1991)
  • K895115 — FRANK INHALER THERMAL S (May 18, 1990)
  • K894215 — EVOLUTION ULTRASONIC (April 16, 1990)

FDA data resources