510(k) K790109
K790109 is an FDA 510(k) premarket notification submitted by Lkc Technologies, Inc. for the device "TELEMETRY, BIOMEDICAL". The FDA issued a decision of Substantially Equivalent on March 16, 1979. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. Lkc Technologies, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1979
- Date Received
- January 17, 1979
- 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