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510(k) K843843

HE TEST by Erich Jaeger, Inc. — Product Code BSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1984
Date Received
October 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Helium, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1640
Review Panel
AN
Submission Type

Other clearances by Erich Jaeger, Inc.

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  • K023796 — MS PAED-BABY BODY (March 3, 2003)
  • 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)

Other clearances for product code BSE

  • K903939 — PANDA HELIUM GAS ANALYZER (January 3, 1991)
  • K841858 — SPIROLOOP (July 11, 1984)