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510(k) K984465

OXYCONALPHA WITH OPTION ECG by Erich Jaeger B.V. — Product Code LOS

K984465 is an FDA 510(k) premarket notification submitted by Erich Jaeger B.V. for the device "OXYCONALPHA WITH OPTION ECG". The FDA issued a decision of Substantially Equivalent on October 27, 1999. Erich Jaeger B.V. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1999
Date Received
December 16, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Erich Jaeger B.V.

  • K023120 — OXYCON MOBILE (November 12, 2003)
  • 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)
  • K980094 — MODIFICATION TO THE OXYCONALPHA (July 28, 1998)
  • K972419 — TOENNIES NEUROSCREEN SYSTEM (April 30, 1998)
  • K960078 — ASTHMA MONITOR (September 20, 1996)

Other clearances for product code LOS

  • K090895 — EKG-PLUS II SOFTWARE (August 26, 2009)
  • K083749 — CARDIOVIEW32 REVIEW MODULE (March 10, 2009)
  • K073376 — PHILIPS ECG ALGORITHM (April 11, 2008)
  • K023034 — CARDIOTOUCH-3000 (November 14, 2002)
  • K011328 — CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH (November 21, 2001)
  • K993616 — CARDIO-CARD INTERPRETATION SYSTEM I (April 10, 2000)
  • K991014 — CASE 8000 EXERCISE TESTING SYSTEM (October 20, 1999)
  • K991735 — MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 (August 19, 1999)
  • K990031 — NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES (April 16, 1999)
  • K984504 — NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES (April 15, 1999)

FDA data resources