The following data is part of a premarket notification filed by Diomedics, Inc. with the FDA for Phaser-2000.
| Device ID | K982546 |
| 510k Number | K982546 |
| Device Name: | PHASER-2000 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | DIOMEDICS, INC. 3817 S.W. 15TH ST. Gainesville, FL 32608 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-21 |
| Decision Date | 1998-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00865198000320 | K982546 | 000 |
| 00865198000313 | K982546 | 000 |
| 00865198000306 | K982546 | 000 |