Home / 510(k) Clearances / K003876

510(k) K003876

US SENSOR #CG-930P; TOCO SENSOR CG-940P by Card Guard Scientific Survival , Ltd. — Product Code HEL

K003876 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "US SENSOR #CG-930P; TOCO SENSOR CG-940P". The FDA issued a decision of Substantially Equivalent on July 9, 2001. The device falls under product code HEL (Monitor, Heart Rate, Fetal, Ultrasonic), a Class II device regulated under 21 CFR 884.2660. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2001
Date Received
December 15, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Heart Rate, Fetal, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
Review Panel
OB
Submission Type

Other clearances by Card Guard Scientific Survival , Ltd.

  • K111745 — KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (August 1, 2011)
  • K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (April 6, 2011)
  • K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, (July 13, 2010)
  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
  • K083174 — HEALTHEPOD (December 17, 2009)
  • K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (January 16, 2009)
  • K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (May 29, 2008)
  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)

Other clearances for product code HEL

  • K010920 — TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING (June 22, 2001)
  • K982651 — COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER (December 11, 1998)
  • K971240 — ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 (June 6, 1997)
  • K930714 — SONICAID MODEL TEAM FECG IUP (August 24, 1995)
  • K933816 — SONICAID MODEL P110 FETAL HEAR DETECTOR (December 22, 1994)
  • K780035 — MINIVISOR (March 6, 1978)

FDA data resources