Recognized standard
F3395/F3395M-19
FDA recognition 17-17 · ASTM · Neurology
Key facts
| Recognition number | 17-17 |
|---|---|
| Designation | F3395/F3395M-19 |
| Title | Standard Specification for Neurosurgical Head Holder Devices |
| Standards developer | ASTM International |
| Specialty area | Neurology |
| Date of entry | Dec 21, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers standards a manufacturer shall meet in the performance testing of neurosurgical head holder devices (skull clamps). 1.2 This specification covers neurosurgical head holder devices (skull clamps) made of metal (nonradiolucent) as well as neurosurgical head holder devices… |
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: