FDA Inspection
Cardiocommand Inc.Cardiocommand Inc. – FDA Inspection, Jul 30, 2026
Record Details
This FDA Inspection record concerns Cardiocommand Inc., with an inspection on July 30, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 154cd627-0258-4c3c-80fe-eb05b6f75104
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1328654
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Cardiocommand Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 17, 2017 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 14, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 17, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 24, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cardiocommand Inc.
- FDA Inspection 1192355 - 2022-12-09
- FDA Inspection 1014353 - 2017-05-17
- FDA Inspection 958200 - 2016-01-14
- FDA Inspection 768206 - 2012-02-17
- FDA Inspection 544508 - 2008-10-24
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