21 CFR 870.2120 — Probe, Blood-Flow, Extravascular
Cardiovascular (CV) · Part 870 Subpart C—Cardiovascular Monitoring Devices · § 870.2120
Identification
An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DPT | Probe, Blood-Flow, Extravascular | 2 | 48 | 3rd Party |
| OFI | Laser Blood Flow Kit | 2 | 0 |