# Cardiovascular, Orthopedic, and Physical Medicine Diagnostic Devices; Reclassification of Cardiopulmonary Bypass Accessory Equipment, Goniometer Device, and Electrode Cable Devices
> **Food and Drug Administration** · Final rule. · Published 2000-04-11 · Effective 2000-05-11 · 65 FR 19317
## Document
- **Document number:** 00-8850
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 19317
- **CFR reference:** 21 CFR 870
- **Publication date:** 2000-04-11
- **Effective date:** 2000-05-11
- **HHS docket:** Docket No. 99N-2210
## Abstract

The Food and Drug Administration (FDA) is reclassifying from class I into class II the cardiopulmonary bypass accessory equipment device that involves an electrical connection to the patient, the goniometer device, and the electrode cable. FDA is also exempting these devices from the premarket notification requirements. FDA is reclassifying these devices on its own initiative based on new information. FDA is taking this action to establish sufficient regulatory controls that will provide reasonable assurance of the safety and effectiveness of these devices.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/04/11/00-8850/cardiovascular-orthopedic-and-physical-medicine-diagnostic-devices-reclassification-of)
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