510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K827584Substantially Equivalent

Japanese Made Microwave Therapy Equipment

Heiwa Electronic Industrial Co., Ltd., Osaka, JP / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K827584 is the FDA 510(k) clearance record for JAPANESE MADE MICROWAVE THERAPY EQUIPMENT, cleared for Heiwa Electronic Industrial Co., Ltd. on . FDA records list one 510(k) clearance for Heiwa Electronic Industrial Co., Ltd. As of , FDA records show no recalls naming K827584.

Clearance record

Decision date
Received
(30 days to decision)
Review panel
Unknown
Applicant
Heiwa Electronic Industrial Co., Ltd. 1510 Shimotawara, Shijonawate, Osaka, JP
Third party review
No