1. LawStack
  2. Title 21 - Food and Drugs
  3. Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
  4. Subchapter H - MEDICAL DEVICES
  5. Part 868 - ANESTHESIOLOGY DEVICES
  6. Subpart B - Diagnostic Devices
  7. 21 CFR § 868.1900
21 CFR § 868.1900
Diagnostic pulmonary-function interpretation calculator
June 25, 2020
CFR

(a) Identification. A diagnostic pulmonary-function interpretation calculator is a device that interprets pulmonary study data to determine clinical significance of pulmonary-function values.

(b) Classification. Class II (performance standards).

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§ 868.1890 Predictive pulmonary-function value calculator
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§ 868.1910 Esophageal stethoscope

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