Ventex-Ia
FDA 510(k) K864641 · Ventech Corp.
510(k) numberK864641
Submission
- Device name
- Ventex-Ia
- Applicant
- Ventech Corp.
Philadelphia, PA, US - Received
- November 26, 1986
- Decision date
- January 28, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IKN – Electromyograph, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Specialty
- Physical Medicine
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| K142494 | ViMoveIKN · Traditional | Dorsavi, Ltd. | 05/28/2015SE |
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| K123399 | Myovision 3.0 Wirefree SystemIKN · Traditional | Precision Biometrics, Inc. | 08/01/2013SE |
| K113074 | Cmap ProIKN · Traditional | Medical Technologies, Inc. | 02/02/2012SE |
| K102610 | Focus Emg DeviceIKN · Traditional | Teleemg, LLC USA | 03/04/2011SE |
| K110048 | Cersr Electromyography SystemIKN · Special | Spinematrix, Inc. | 01/26/2011SE |
Questions and answers
When was Ventex-Ia cleared by the FDA?
Ventex-Ia (K864641) received a 510(k) decision of Substantially Equivalent on January 28, 1987, 63 days after the submission was received.
What is the product code of K864641?
The FDA product code is IKN – Electromyograph, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 890.1375.