DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)

Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

DYNATRONICS CORP.

The following data is part of a premarket notification filed by Dynatronics Corp. with the FDA for Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (optional Accessory).

Pre-market Notification Details

Device IDK031329
510k NumberK031329
Device Name:DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)
ClassificationUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Applicant DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City,  UT  84121
ContactRon Hatch
CorrespondentRon Hatch
DYNATRONICS CORP. 7030 PARK CENTRE DR. Salt Lake City,  UT  84121
Product CodeIMI  
Subsequent Product CodeGZJ
Subsequent Product CodeILY
Subsequent Product CodeIPF
Subsequent Product CodeLIH
CFR Regulation Number890.5300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-04-28
Decision Date2003-10-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10660584000338 K031329 000
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10660584000352 K031329 000
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10660584000031 K031329 000
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10660584000055 K031329 000
10660584000109 K031329 000
10660584000116 K031329 000
10660584000123 K031329 000
10660584000130 K031329 000
10660584000185 K031329 000

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