GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)— 510(k) K921929
Substantially EquivalentGeneral Devices
FDA 510(k) clearance K921929 for GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION), Substantially Equivalent on 1992-09-18. Applicant: General Devices. Device class: 2.
Clearance details
- Applicant
- General Devices
- Product code
- Code DXH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2920
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bogota, NJ, US
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