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510(k) K932744

FLOWSCREEN by Erich Jaeger, Inc. — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1994
Date Received
June 8, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Erich Jaeger, Inc.

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  • K021138 — SLEEPSCREEN/APNOESCREEN CARDIO (February 12, 2003)
  • K000396 — APNOESCREEN PRO, ALPHA SCREEN PRO (December 27, 2000)
  • K001502 — AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO (July 12, 2000)
  • K000648 — SPIRO PRO (March 29, 2000)
  • K992214 — OXYCON PRO (February 22, 2000)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K980094 — MODIFICATION TO THE OXYCONALPHA (July 28, 1998)
  • K972419 — TOENNIES NEUROSCREEN SYSTEM (April 30, 1998)

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  • K173937 — SpiroSphere (February 15, 2019)
  • K161534 — EasyOne Pro Respiratory Analysis System (February 22, 2017)