The following data is part of a premarket notification filed by Analytic Technology with the FDA for Analytic Technology Endo Analyzer Model 8001.
| Device ID | K864500 |
| 510k Number | K864500 |
| Device Name: | ANALYTIC TECHNOLOGY ENDO ANALYZER MODEL 8001 |
| Classification | Locator, Root Apex |
| Applicant | ANALYTIC TECHNOLOGY 15233 NORTHEAST 90TH ST. Redmond, WA 98052 |
| Contact | Johan Masreliez |
| Correspondent | Johan Masreliez ANALYTIC TECHNOLOGY 15233 NORTHEAST 90TH ST. Redmond, WA 98052 |
| Product Code | LQY |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-14 |
| Decision Date | 1987-03-19 |