GEM-CRIT CHECK— 510(k) K871686
Substantially EquivalentDiamond Sensor Systems
FDA 510(k) clearance K871686 for GEM-CRIT CHECK, Substantially Equivalent on 1987-06-18. Applicant: Diamond Sensor Systems. Device class: 2.
Clearance details
- Applicant
- Diamond Sensor Systems
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DRY
view allMore clearances from Diamond Sensor Systems
view allAdverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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.