The following data is part of a premarket notification filed by Integration Diagnostics Ltd with the FDA for Osstell Resonance Frequency Analyzer.
| Device ID | K003714 |
| 510k Number | K003714 |
| Device Name: | OSSTELL RESONANCE FREQUENCY ANALYZER |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | INTEGRATION DIAGNOSTICS LTD 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Contact | Constance Bundy |
| Correspondent | Constance Bundy INTEGRATION DIAGNOSTICS LTD 6470 RIVERVIEW TERRACE Minneapolis, MN 55432 |
| Product Code | EKX |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-01 |
| Decision Date | 2001-08-09 |