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510(k) K031514

MODIFICATION TO TRUPEAK PEAK FLOW METER by Monaghan Medical Corp. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2003
Date Received
May 14, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

Other clearances by Monaghan Medical Corp.

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  • 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)
  • K944512 — TRUZONE PFM DISPOSABLE MOUTHPIECE (November 2, 1994)

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