HICP200 Patient/Monitor Interconnect Cable— 510(k) K161010
Substantially EquivalentInnerspace Neuro Solutions, Inc.
FDA 510(k) clearance K161010 for HICP200 Patient/Monitor Interconnect Cable, Substantially Equivalent on 2016-10-20. Applicant: Innerspace Neuro Solutions, Inc..
Clearance details
- Applicant
- Innerspace Neuro Solutions, Inc.
- Product code
- Code GWM
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tustin, CA, US
Adverse events under product code GWM
product code GWM- Death
- 21
- Injury
- 732
- Malfunction
- 2,063
- Other
- 1
- Total
- 2,817
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.