Home / 510(k) Clearances / K023713

510(k) K023713

SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000 by Sontra Medical, Inc. — Product Code KRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2004
Date Received
November 4, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Electrode, Surface, Electrocardiographic
Device Class
Class II
Regulation Number
870.2370
Review Panel
CV
Submission Type

Other clearances by Sontra Medical, Inc.

  • K040525 — SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D20 (August 17, 2004)

Other clearances for product code KRC

  • K872370 — BIOMA 3500 (December 7, 1987)
  • K874155 — CIRCAMED MONITOR REMOTE START CONDUCTANCE METER (November 23, 1987)
  • K874327 — SKIN PREP ANALYZER (November 23, 1987)
  • K840358 — IMPEDANCE/8200 MONITOR-MODEL 8300 (October 30, 1984)
  • K833619 — CONDUCTANCE METER (January 27, 1984)
  • K830876 — PREP-CHECK (May 18, 1983)
  • K830823 — Z VIEW METER MODEL 300 (May 18, 1983)
  • K813358 — GERARD MEDICAL ELECTRODE TESTER (December 29, 1981)
  • K780501 — ELECTRODE TESTER (May 19, 1978)
  • K771014 — TS-100 TEST SYSTEM (June 14, 1977)