Recognized standard
63045 Edition 1.0 2020-05
FDA recognition 6-500 · IEC · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-500 |
|---|---|
| Designation | 63045 Edition 1.0 2020-05 |
| Title | Ultrasonics - Non-focusing short pressure pulse sources including ballistic pressure pulse sources - Characteristics of fields |
| Standards developer | International Electrotechnical Commission |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | May 29, 2024 |
| Device classes | Class 1 |
| Scope (excerpt) | This document is applicable to: - therapy equipment using extracorporeally induced non-focused or weakly focused pressure pulses; - therapy equipment producing extracorporeally induced non-focused or weakly focused mechanical energy, where the pressure pulses are released as single events of… |
At a glance
- 1–9 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: