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510(k) K882080

MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. by Aequitron Medical, Inc. — Product Code HFM

K882080 is an FDA 510(k) premarket notification submitted by Aequitron Medical, Inc. for the device "MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS.". The FDA issued a decision of Substantially Equivalent on March 1, 1989. 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. Aequitron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 1989
Date Received
May 17, 1988
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 Aequitron Medical, Inc.

  • K961972 — MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR (April 18, 1997)
  • K952880 — MODEL LP-1000 VOLUME VENTILATOR (June 20, 1996)
  • K944654 — OXYGEN CONCENTRATION INDICATOR (November 8, 1994)
  • K914424 — MODEL 6213 REMOTE ALARM (September 10, 1992)
  • K915381 — PORTABLE OXYGEN GENERATOR (March 11, 1992)
  • K911399 — NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST) (September 19, 1991)
  • K903020 — RESPIRATION/HEART RATE MONITOR MODEL 9500/9550 (April 10, 1991)
  • K903010 — CONTINUOUS VOLUME VENTILATOR MODEL LP10 (November 30, 1990)
  • K905244 — MODEL LP6 VENTILATOR, MODIFICATION (November 30, 1990)
  • K902785 — MODIFIED MODELS 9500,9550,9200,8200,HEART RATE MON (July 13, 1990)

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