The following data is part of a premarket notification filed by Cgr Medical Corp. with the FDA for Phasix-high Frequency Generator.
| Device ID | K834306 |
| 510k Number | K834306 |
| Device Name: | PHASIX-HIGH FREQUENCY GENERATOR |
| Classification | Assembly, Tube Housing, X-ray, Diagnostic |
| Applicant | CGR MEDICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ITY |
| CFR Regulation Number | 892.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-04 |
| Decision Date | 1983-12-29 |