{"data":{"id":"us/21-cfr-868.1170","jurisdiction":"us","citation":"21 CFR 868.1170","heading":"Indwelling blood hydrogen ion concentration (pH) analyzer.","body":"(a) Identification. An indwelling blood hydrogen ion concentration (pH) analyzer is a device that consists of a catheter-tip pH electrode and that is used to measure, in vivo, the hydrogen ion concentration (pH) in blood to aid in determining the patient's acid-base balance.\n(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA.”","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 868—ANESTHESIOLOGY DEVICES","Subpart B—Diagnostic 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":"233aedecd850cad1a4cc8a55443a721be61ee12fda44d533ffff448c0d7cbaa0","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-868.1150","next":"us/21-cfr-868.1200"},"notice":"GroundRules: Original legal text. Not legal advice."}