Recognized standard
E1104-98 (Reapproved 2016)
FDA recognition 6-124 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-124 |
|---|---|
| Designation | E1104-98 (Reapproved 2016) |
| Title | Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2 |
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: