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510(k) K823555

MAGTARAK RESPIRATORY MONITOR & FLOW SENS by Penlon, Inc. — Product Code BZK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1983
Date Received
December 1, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Monitoring (W/Wo Alarm)
Device Class
Class II
Regulation Number
868.1850
Review Panel
AN
Submission Type

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  • K960944 — PPV VAPORIZER (MODIFICATION) (April 2, 1996)
  • K953179 — CLM LARYNGOSCOPE (October 6, 1995)
  • K942545 — SIGMA ELITE (February 3, 1995)
  • K936046 — SIGMA ELITE (November 4, 1994)

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  • K092217 — MERCURY VCO2 (August 21, 2009)