Recognized standard
11073-10424 First edition 2016-06-15
FDA recognition 13-94 · ISO · Software/Informatics
Key facts
| Recognition number | 13-94 |
|---|---|
| Designation | 11073-10424 First edition 2016-06-15 |
| Title | Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Software/Informatics |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
| Scope (excerpt) | Within the context of the ISO/IEEE 11073 family of standards for device communication, this standard establishes a normative definition of the communication between sleep apnoea breathing therapy equipment and managers (e.g., cell phones, personal computers, personal health appliances, set top… |
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: