{"data":{"id":"us/21-cfr-870.2600","jurisdiction":"us","citation":"21 CFR 870.2600","heading":"Signal isolation system.","body":"(a) Identification. A signal isolation system is a device that electrically isolates the patient from equipment connected to the commercial power supply received from a utility company. This isolation may be accomplished, for example, by transformer coupling, acoustic coupling, or optical coupling.\n(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 870—CARDIOVASCULAR DEVICES","Subpart C—Cardiovascular Monitoring Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"0308800d893ff68f76669111dd3f35f09e50c3ecdb462318fb6e33becbaa7b98","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-870.2450","next":"us/21-cfr-870.2620"},"notice":"GroundRules: Original legal text. Not legal advice."}