| K-number | K914231 |
| Device name | ELPHA 2000 |
| Applicant | Biometer Intl. A/S |
| Product code | IPF |
| Device class | Class II |
| Decision date | May 28, 1992 |
| Decision | Substantially Equivalent |
| Regulation | 890.5850 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov