PHASER-2000

Lamp, Infrared, Therapeutic Heating

DIOMEDICS, INC.

The following data is part of a premarket notification filed by Diomedics, Inc. with the FDA for Phaser-2000.

Pre-market Notification Details

Device IDK982546
510k NumberK982546
Device Name:PHASER-2000
ClassificationLamp, Infrared, Therapeutic Heating
Applicant DIOMEDICS, INC. 3817 S.W. 15TH ST. Gainesville,  FL  32608
Product CodeILY  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-21
Decision Date1998-09-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00865198000320 K982546 000
00865198000313 K982546 000
00865198000306 K982546 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.