510(k) K921929
K921929 is an FDA 510(k) premarket notification submitted by General Devices for the device "GEMSCOM SERIES 300 12-LEAD ECG (12-LEAD OPTION)". The FDA issued a decision of Substantially Equivalent on September 18, 1992. The device falls under product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone), a Class II device regulated under 21 CFR 870.2920. General Devices has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1992
- Date Received
- April 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Electrocardiograph, Telephone
- Device Class
- Class II
- Regulation Number
- 870.2920
- Review Panel
- CV
- Submission Type