Telemetry, Biomedical
FDA 510(k) K790109 · Lkc Technologies, Inc.
510(k) numberK790109
Submission
- Device name
- Telemetry, Biomedical
- Applicant
- Lkc Technologies, Inc.
Mchenry, IL, US - Received
- January 17, 1979
- Decision date
- March 16, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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Questions and answers
When was Telemetry, Biomedical cleared by the FDA?
Telemetry, Biomedical (K790109) received a 510(k) decision of Substantially Equivalent on March 16, 1979, 58 days after the submission was received.
What is the product code of K790109?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.