Product code HFM
- Device name
- Monitor, Uterine Contraction, External (For Use In Clinic)
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2720
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P890063S004 | GENESIS HOME UTERINE ACTIVITY MONITORING SYSTEM (HUAM) | Matria Healthcare, Inc. | 1995-06-16 |
| P890063S003 | GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS. | Matria Healthcare, Inc. | 1994-01-31 |
| P890063S002 | GENESIS SYSTEM & TERM GUARD I & TERM GUARD II SYS. | Matria Healthcare, Inc. | 1991-04-10 |
| P890063 | GENESIS(R) HOME UTERINE ACTIVITY MONITORING SYSTEM | Matria Healthcare, Inc. | 1990-09-12 |
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140163 | KOALA TOCO | Clinical Innovations, LLC | 2014-05-29 |
| K061044 | FEATHERLITE AQUA TOCODYNAMOMETER | Ventrex, Inc. | 2006-07-12 |
| K040392 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | American I.V. Products, Inc. | 2004-09-14 |
| K994353 | SECURELINE DISPOSABLE FETAL MONITORING STRAPS #3860 AND #3565 | Precision Dynamics Corp. | 2000-03-22 |
| K992811 | TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORING | Epic Medical Equipment Services, Inc. | 2000-01-18 |
| K954847 | DISCO UTERINE CONTRACTION TRANSDUCER & ACCESSORIES | Ocg Systems, Inc. | 1996-05-22 |
| K952579 | TOCO TRANSDUCER | Scientific Device Manufacturer, LLC | 1995-08-04 |
| K920152 | BUBBLE TOCO | Utah Medical Products, Inc. | 1993-05-26 |
| K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER | Graphic Controls Corp. | 1991-03-29 |
| K904691 | AIR-SHIELDS VICKERS TELESCAN TELECOM DISPLAY SYST | Air-Shields Vickers, Inc. | 1991-02-19 |
| K903623 | MODEL600 UTERINE ACTIVITY MONITOR | Corometrics Medical Systems, Inc. | 1990-11-07 |
| K902104 | ORION WATCHGUARD | Orion Industries | 1990-10-25 |
| K894030 | MODEL 37 UTERINE CONTRACTION ACTIVITY MONITOR | Healthdyne, Inc. | 1990-01-22 |
| K893770 | TERM GUARD II DEVICE | Tokos Medical Corp. | 1989-11-03 |
| K891997 | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER | Corometrics Medical Systems, Inc. | 1989-06-08 |
| K882080 | MODEL NUMBER (TBD) TOCO DATA TELEPHONE TRANS. SYS. | Aequitron Medical, Inc. | 1989-03-01 |
| K873150 | PDS, MODEL NST 40 FETAL MONITOR, RECORDER & TRANS. | Pediatric Diagnostic Service | 1988-03-11 |
| K874631 | HEALTHPHONE TOCO MODEL | Carelink | 1988-03-11 |
| K860933 | AIR-CUSHION TOCOTONOMETER | International Biomedics, Inc. | 1986-07-09 |
| K853856 | EXTERNAL UTERINE CONTRACTION MONITOR-TOKODYNAMOMET | Aequitron Medical, Inc. | 1986-03-12 |
| K843011 | TERM GUARD 5000 UTERINE ACTIVITY | Tokos Medical Corp. | 1984-11-01 |
| K840747 | TOCO DATA TELEPHONE TRANSMITTER DT100P | Advantage Medical Systems, Inc. | 1984-06-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00884838093195 | Avalon Ultrasound Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093201 | Avalon ECG/IUP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093188 | Avalon Toco+ MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093218 | Avalon Toco MP Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 00884838093225 | Avalon Toco+ Transducer | Philips Medizin Systeme Böblingen GmbH | 2021-03-08 |
| 20884838059324 | Avalon Fetal & Maternal Patch | Philips Medical Systems Hsg | 2020-05-25 |
| 00884838068179 | Avalon CL Fetal & Maternal Pod | Philips Medizin Systeme Böblingen GmbH | 2020-05-22 |
| 00840682142571 | TOCO TRANSDUCER | WIPRO GE HEALTHCARE PRIVATE LIMITED | 2018-11-01 |
| M745FM10839 | AIV | AMERICAN IV PRODUCTS, INC. | 2016-09-02 |
| M745FM10840 | AIV | AMERICAN IV PRODUCTS, INC. | 2016-09-02 |
| M745FM10841 | AIV | AMERICAN IV PRODUCTS, INC. | 2016-09-02 |
| 00814247020284 | Koala Toco® | CLINICAL INNOVATIONS, LLC | 2016-09-01 |
| B249VA003120 | FEATHERLITE TOCO PLUS | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA003111 | FEATHERLITE TOCO PLUS | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA003110 | FEATHERLITE TOCO PLUS | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA003121 | FEATHERLITE TOCO PLUS | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA003101 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA003100 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA002191 | FEATHERLITE AQUA | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA002190 | FEATHERLITE AQUA | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA002030 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA002020 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA001061 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA001060 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA000381 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| B249VA000380 | FEATHERLITE TOCO | PARKER-HANNIFIN CORPORATION | 2016-08-18 |
| 00840682104296 | N/A | WIPRO GE HEALTHCARE PRIVATE LIMITED | 2016-06-24 |
| 00840682104227 | NA | WIPRO GE HEALTHCARE PRIVATE LIMITED | 2016-06-24 |
| 00840682104210 | N/A | WIPRO GE HEALTHCARE PRIVATE LIMITED | 2016-06-24 |
| 00840682104111 | N/A | WIPRO GE HEALTHCARE PRIVATE LIMITED | 2016-06-24 |