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510(k) K913518

TA620 TREADMILL CONTROLLER by Siemens Burdick, Inc. — Product Code IOL

K913518 is an FDA 510(k) premarket notification submitted by Siemens Burdick, Inc. for the device "TA620 TREADMILL CONTROLLER". The FDA issued a decision of Substantially Equivalent on October 24, 1991. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Siemens Burdick, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1991
Date Received
August 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Treadmill, Powered
Device Class
Class I
Regulation Number
890.5380
Review Panel
PM
Submission Type

Other clearances by Siemens Burdick, Inc.

  • K915327 — ELITE II ELECTROCARDIOGRAPH,MODIFIED (October 9, 1992)
  • K915225 — MEGACART (July 1, 1992)
  • K915202 — INTERNAL MODEM FOR THE E560 ELECTROCARDIOGRAPH (May 15, 1992)
  • K914969 — E350I ELECTROCARDIOGRAPH (March 26, 1992)
  • K910634 — DC200 DEFIBRILLATOR (July 24, 1991)
  • K910867 — T600 TREADMILL (May 31, 1991)

Other clearances for product code IOL

  • K950376 — PARKER MODEL PM (September 6, 1995)
  • K950377 — PARKER MODEL PE (September 6, 1995)
  • K925839 — TRACKMASTER (June 24, 1993)
  • K930261 — RTM REHABILITATION TREADMILL, MODEL #945-200 (May 26, 1993)
  • K904556 — MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB (December 18, 1991)
  • K910867 — T600 TREADMILL (May 31, 1991)
  • K911751 — MEDTRACK TREADMILL (May 29, 1991)
  • K897179 — ORBITER(TM) TREADMILL (February 15, 1990)
  • K895104 — AQUATREX UNDERWATER TREADMILL SYSTEM (December 4, 1989)
  • K893032 — PACER R 9 TREADMILL (July 27, 1989)

FDA data resources