Orthomon
FDA 510(k) K061113 · Axon Systems, Inc.
510(k) numberK061113
Submission
- Device name
- Orthomon
- Applicant
- Axon Systems, Inc.
Hauppauge, NY, US - Received
- April 21, 2006
- Decision date
- May 23, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K061639 | Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and…GWF · Traditional | 11/01/2006SE |
| K050798 | Eclipse Neurological WorkstationGWF · Traditional | 08/15/2005SE |
| K050194 | Axon Systems Subdermal Needle ElectrodesGXZ · Traditional | 04/26/2005SE |
| K032741 | Epochxp Neurological Workstation,Epochxp Lite Neurological WorkstationGWF · Traditional | 12/16/2003SE |
| K022785 | Epoch XP Neurological Workstation; Epoch XP Lite Neurological WorkstationGWQ · Special | 10/09/2002SE |
| K010697 | Unique Ambulatory EEGGWQ · Traditional | 06/06/2001SE |
| K002316 | Phoenix Digital EEGGWQ · Traditional | 10/26/2000SE |
Questions and answers
When was Orthomon cleared by the FDA?
Orthomon (K061113) received a 510(k) decision of Substantially Equivalent on May 23, 2006, 32 days after the submission was received.
What is the product code of K061113?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.