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510(k) K023097

TRUEZONE PEAK FLOW METER by Monaghan Medical Corp. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2003
Date Received
September 18, 2002
Clearance Type
Abbreviated
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.

  • K123945 — STRIVE DUAL ZONE PEAK FLOW METER (April 17, 2013)
  • K031514 — MODIFICATION TO TRUPEAK PEAK FLOW METER (May 23, 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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  • K180487 — Peak.me (October 26, 2018)
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