Medi-Trace(R) Disposable Tocotonometer
FDA 510(k) K910282 · Graphic Controls Corp.
510(k) numberK910282
Submission
- Device name
- Medi-Trace(R) Disposable Tocotonometer
- Applicant
- Graphic Controls Corp.
Buffalo, NY, US - Received
- January 23, 1991
- Decision date
- March 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HFM – Monitor, Uterine Contraction, External (For Use In Clinic)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2720
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K140163 | Koala TocoHFM · Traditional | Clinical Innovations, LLC | 05/29/2014SE |
| K061044 | Featherlite Aqua TocodynamometerHFM · Traditional | Ventrex, Inc. | 07/12/2006SE |
| K040392 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringHFM · Traditional | American I.V. Products, Inc. | 09/14/2004SE |
| K013477 | Toco Lite, Model TD-01HFM · Traditional | Ventrex, Inc. | 01/17/2002SE |
| K994353 | Secureline Disposable Fetal Monitoring Straps #3860 and #3565HFM · Traditional | Precision Dynamics Corp. | 03/22/2000SE |
| K992811 | Transducers for Ultrasound and Tocodynamometer Fetal MonitoringHFM · Abbreviated | Epic Medical Equipment Services, Inc. | 01/18/2000SE |
| K954847 | Disco Uterine Contraction Transducer & AccessoriesHFM · Traditional | Ocg Systems, Inc. | 05/22/1996SE |
| K952579 | Toco TransducerHFM · Traditional | Scientific Device Manufacturer, LLC | 08/04/1995SE |
| K920152 | Bubble TocoHFM · Traditional | Utah Medical Products, Inc. | 05/26/1993SE |
| K904691 | Air-Shields Vickers Telescan Telecom Display SystHFM · Traditional | Air-Shields Vickers, Inc. | 02/19/1991SE |
More from Air-Shields Vickers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981964 | Medi-Trace 4103 Neonatal ElectrodeDRX · Traditional | 11/13/1998SE |
| K983287 | Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 11/05/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | 07/14/1998SE |
| K980857 | Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing ElectrodeMKJ · Traditional | 05/12/1998SE |
| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 08/27/1997SE |
| K964387 | Point of Use II Sharps-A-GatorMMK · Traditional | 03/27/1997SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | 01/22/1997SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | 11/19/1996SE |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional | 11/15/1996SE |
| K960968 | Medi-Trace 200, Medi-Trace 200-30DRX · Traditional | 10/28/1996SE |
Questions and answers
When was Medi-Trace(R) Disposable Tocotonometer cleared by the FDA?
Medi-Trace(R) Disposable Tocotonometer (K910282) received a 510(k) decision of Substantially Equivalent on March 29, 1991, 65 days after the submission was received.
What is the product code of K910282?
The FDA product code is HFM – Monitor, Uterine Contraction, External (For Use In Clinic), a Class II (moderate risk) device regulated under 21 CFR 884.2720.