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510(k) K822437

MONAGHAN AEROCHAMBER by Monaghan Medical Corp. — Product Code BYP

K822437 is an FDA 510(k) premarket notification submitted by Monaghan Medical Corp. for the device "MONAGHAN AEROCHAMBER". The FDA issued a decision of Substantially Equivalent on November 3, 1982. The device falls under product code BYP (Mouthpiece, Breathing), a Class I device regulated under 21 CFR 868.5620. Monaghan Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1982
Date Received
August 13, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mouthpiece, Breathing
Device Class
Class I
Regulation Number
868.5620
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 BYP

  • K955657 — NORTH STATE PLASTICS RESPIRATORY MOUTHPIECE (March 12, 1996)
  • K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE (November 2, 1994)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K872037 — AEROCHAMBER (July 24, 1987)
  • K865093 — SAFE-T-SHIELD MOUTHPIECE (January 15, 1987)
  • K863049 — INHALATION AID (October 15, 1986)
  • K862788 — MP-4400 MOUTHPIECE-FLANGE SEAL (August 1, 1986)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)

FDA data resources