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510(k) K904691

AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST by Air-Shields Vickers, Inc. — Product Code HFM

K904691 is an FDA 510(k) premarket notification submitted by Air-Shields Vickers, Inc. for the device "AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST". The FDA issued a decision of Substantially Equivalent on February 19, 1991. The device falls under product code HFM (Monitor, Uterine Contraction, External (For Use In Clinic)), a Class II device regulated under 21 CFR 884.2720. Air-Shields Vickers, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1991
Date Received
October 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Uterine Contraction, External (For Use In Clinic)
Device Class
Class II
Regulation Number
884.2720
Review Panel
OB
Submission Type

Other clearances by Air-Shields Vickers, Inc.

  • K924679 — OXYCARE(TM) OXYGEN CONTROLLER/MONITOR (February 21, 1995)
  • K924297 — DEWETTE 2 ISOLETTE INCUBATOR HUMIDIFIER (March 18, 1993)
  • K912908 — AIR-SHIELDS MICRO-LITE PHOTOTHERAPY SYSTEM (December 13, 1991)
  • K912909 — SOLAIR (TM) INFANT INCUBATOR TRANSPARENT HOOD WARM (November 5, 1991)
  • K912910 — C100 INFANT INCUBATOR SHELF/MOUNT RAIL SYSTEM (October 30, 1991)
  • K903378 — MODEL C286 ISOLETTE INFANT INCUBATOR (October 15, 1990)
  • K895782 — NEONATAL INCUBATOR (ACCESSORY) (December 7, 1989)
  • K884086 — C100 QT VARIABLE HEIGHT ADJUSTMENT INCUBATOR (November 14, 1988)

Other clearances for product code HFM

  • K140163 — KOALA TOCO (May 29, 2014)
  • K061044 — FEATHERLITE AQUA TOCODYNAMOMETER (July 12, 2006)
  • K040392 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (September 14, 2004)
  • K013477 — TOCO LITE, MODEL TD-01 (January 17, 2002)
  • K994353 — SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (March 22, 2000)
  • K992811 — TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (January 18, 2000)
  • K954847 — DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES (May 22, 1996)
  • K952579 — TOCO TRANSDUCER (August 4, 1995)
  • K920152 — BUBBLE TOCO (May 26, 1993)
  • K910282 — MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (March 29, 1991)

FDA data resources