21 CFR 870.1120 — Blood Pressure Cuff
Cardiovascular (CV) · Part 870 Subpart B—Cardiovascular Diagnostic Devices · § 870.1120
Identification
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DXQ | Blood Pressure Cuff | 2 | 197 | 3rd Party |
| NPP | Reprocessed Blood Pressure Cuff | 2 | 1 | 3rd Party |
| OED | Antimicrobial Blood Pressure Cuff | 2 | 2 | 3rd Party |
