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 |