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510(k) K944512

TRUZONE PFM DISPOSABLE MOUTHPIECE by Monaghan Medical Corp. — Product Code BYP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1994
Date Received
September 15, 1994
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

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  • 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)
  • 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)
  • K853575 — MEDIPART MOUTHPIECE MP-1010 (October 29, 1985)
  • K853574 — MEDIPART DISPOS. MOUTHPIECE W/22MM O.D. MP-4411 (October 29, 1985)
  • K853572 — MEDIPART DISPOS. MOUTHPIECE W/2MM I.D. MP-4410 (October 29, 1985)
  • K853266 — PLASTIC MOUTH BARRIER HSV-I (October 29, 1985)