Home / 510(k) Clearances / K791892

510(k) K791892

TAPE-A-TRACE by Instromedix, Inc. — Product Code DXM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1979
Date Received
September 25, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Densitometer
Device Class
Class II
Regulation Number
870.1450
Review Panel
CV
Submission Type

Other clearances by Instromedix, Inc.

  • K010945 — HEARTCARD, MODEL 5258 (June 12, 2001)
  • K964408 — POSEIDON CARDIAC MONITORING SYSTEM (PCMS) (July 23, 1997)
  • K964036 — CARDIOMAGIC 2000 SOFTWARE (July 18, 1997)
  • K955060 — ACCELERATED TRANSMISSION PROTOCOL (April 8, 1996)
  • K951096 — LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER (January 16, 1996)
  • K945476 — HEARTHWATCH III(TM) (November 9, 1995)
  • K950003 — CARDIOMAGIC(R) SOFTWARE ENHANCEMENTS (October 31, 1995)
  • K944362 — HEARTCARD CARDIAC EVENT MONITOR (September 7, 1995)
  • K943931 — CARRYALL ENHANCEMENTS (April 4, 1995)
  • K935586 — PRINCE (November 8, 1994)

Other clearances for product code DXM

  • K781692 — CALIBRATOR, DYNAMIC (November 29, 1978)