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510(k) K843855

ERGOTEST 40 & 45 by Erich Jaeger, Inc. — Product Code ISP

K843855 is an FDA 510(k) premarket notification submitted by Erich Jaeger, Inc. for the device "ERGOTEST 40 & 45". The FDA issued a decision of Substantially Equivalent on November 27, 1984. The device falls under product code ISP (Valve, Prosthesis), a Class I device regulated under 21 CFR 890.3420. Erich Jaeger, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1984
Date Received
October 1, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Prosthesis
Device Class
Class I
Regulation Number
890.3420
Review Panel
PM
Submission Type

Other clearances by Erich Jaeger, Inc.

  • 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)
  • K984465 — OXYCONALPHA WITH OPTION ECG (October 27, 1999)
  • K980094 — MODIFICATION TO THE OXYCONALPHA (July 28, 1998)
  • K972419 — TOENNIES NEUROSCREEN SYSTEM (April 30, 1998)

FDA data resources