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510(k) K854283

CAMBRIDGE MODEL XT1000 by Cambridge Medical Instruments, Inc. — Product Code IOL

K854283 is an FDA 510(k) premarket notification submitted by Cambridge Medical Instruments, Inc. for the device "CAMBRIDGE MODEL XT1000". The FDA issued a decision of Substantially Equivalent on November 13, 1985. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Cambridge Medical Instruments, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1985
Date Received
October 24, 1985
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 Cambridge Medical Instruments, Inc.

  • K896771 — EKG, ECG KENZ, ECG 302 (February 26, 1990)
  • K896772 — EKG, ECG KENZ, ECG 303 (February 26, 1990)
  • K895961 — MODEL MC6500 ELECTROCARDIOGRAPH (January 4, 1990)
  • K883454 — MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPH (January 25, 1989)
  • K871993 — MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPH (November 23, 1987)
  • K862748 — MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATION (August 25, 1986)
  • K854282 — PREVIEW XT (January 8, 1986)

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)
  • K913518 — TA620 TREADMILL CONTROLLER (October 24, 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)

FDA data resources