Atlas FDA

BUBBLE TOCO

FDA 510(k) clearance K920152 · decided 1993-05-26

Clearance details

K-number
K920152
Device name
BUBBLE TOCO
Applicant
Utah Medical Products, Inc.
Decision
Substantially Equivalent
Date received
1992-01-13
Decision date
1993-05-26
Days to decision
499 days
Clearance type
Traditional
Product code
HFM
Device class
2
Regulation number
884.2720
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Midvale, UT, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
KOALA TOCO (K140163)Clinical Innovations, LLC2014-05-29
FEATHERLITE AQUA TOCODYNAMOMETER (K061044)Ventrex, Inc.2006-07-12
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K040392)American I.V. Products, Inc.2004-09-14
TOCO LITE, MODEL TD-01 (K013477)Ventrex, Inc.2002-01-17
SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 (K994353)Precision Dynamics Corp.2000-03-22
TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING (K992811)Epic Medical Equipment Services, Inc.2000-01-18
DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES (K954847)Ocg Systems, Inc.1996-05-22
TOCO TRANSDUCER (K952579)Scientific Device Manufacturer, LLC1995-08-04
MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER (K910282)Graphic Controls Corp.1991-03-29
AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST (K904691)Air-Shields Vickers, Inc.1991-02-19
MODEL600 UTERINE ACTIVITY MONITOR (K903623)Corometrics Medical Systems, Inc.1990-11-07
ORION WATCHGUARD (K902104)Orion Industries1990-10-25

Recalls involving this device

No recalls on record reference this clearance.