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510(k) K791892

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

K791892 is an FDA 510(k) premarket notification submitted by Instromedix, Inc. for the device "TAPE-A-TRACE". The FDA issued a decision of Substantially Equivalent on November 5, 1979. The device falls under product code DXM (Densitometer), a Class II device regulated under 21 CFR 870.1450. Instromedix, Inc. has at least 10 other 510(k) clearances on record.

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)

FDA data resources