510(k) K013533
K013533 is an FDA 510(k) premarket notification submitted by General Devices for the device "EMS TELEMEDICINE OPTION (FOR GEMS SERIES 4000)". The FDA issued a decision of Substantially Equivalent on January 18, 2002. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. General Devices has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 2002
- Date Received
- October 23, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 870.2910
- Review Panel
- CV
- Submission Type