ORTHOMON— 510(k) K061113
Substantially EquivalentAxon Systems, Inc.
FDA 510(k) clearance K061113 for ORTHOMON, Substantially Equivalent on 2006-05-23. Applicant: Axon Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Axon Systems, Inc.
- Product code
- Code GWF
- Device class
- Class 2
- Regulation
- 21 CFR 882.1870
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hauppauge, NY, US
Recent devices under product code GWF
view allMore clearances from Axon Systems, Inc.
view all- K090838 — STIMULUS/DISSECTION INSTRUMENTS
- K062996 — DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
- K062198 — SUNSPOTS PRE-GELLED SURFACE ELECTRODES
- K061639 — ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
- K050798 — ECLIPSE NEUROLOGICAL WORKSTATION
Adverse events under product code GWF
product code GWF- Malfunction
- 2,364
- Other
- 4
- Total
- 2,368
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.