Air-Cushion Tocotonometer
FDA 510(k) K860933 · International Biomedics, Inc.
510(k) numberK860933
Submission
- Device name
- Air-Cushion Tocotonometer
- Applicant
- International Biomedics, Inc.
Bothell, WA, US - Received
- March 12, 1986
- Decision date
- July 9, 1986
- 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 |
| K910282 | Medi-Trace(R) Disposable TocotonometerHFM · Traditional | Graphic Controls Corp. | 03/29/1991SE |
More from Graphic Controls Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K031096 | Modification to Transport Incubator 185FPL · Special | 06/24/2003SE |
| K862072 | Fetascan Ultrasound Transducer Ibi# 101B00054-01HGL · Traditional | 07/09/1986SE |
| K860295 | Fetascan 1500HGM · Traditional | 05/19/1986SE |
| K852439 | Feta Scan 1000 Obstetrical ImagerHEM · Traditional | 08/30/1985SE |
Questions and answers
When was Air-Cushion Tocotonometer cleared by the FDA?
Air-Cushion Tocotonometer (K860933) received a 510(k) decision of Substantially Equivalent on July 9, 1986, 119 days after the submission was received.
What is the product code of K860933?
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.