Recognized standard
Std 1708-2014
FDA recognition 3-168 · IEEE · Cardiovascular
Key facts
| Recognition number | 3-168 |
|---|---|
| Designation | Std 1708-2014 |
| Title | Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)] |
| Standards developer | Institute of Electrical and Electronic Engineers |
| Specialty area | Cardiovascular |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | The intent of this standard is to establish objective performance evaluation of wearable, cuffless blood pressure (BP) measuring devices. The standard is independent of the form of the device or the vehicle to which the device is attached or in which it is embedded. The standard is applicable to all… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: