APOLLO HEART RATE INDICATOR

Device, Biofeedback

KEY TRONIC CORP.

The following data is part of a premarket notification filed by Key Tronic Corp. with the FDA for Apollo Heart Rate Indicator.

Pre-market Notification Details

Device IDK791207
510k NumberK791207
Device Name:APOLLO HEART RATE INDICATOR
ClassificationDevice, Biofeedback
Applicant KEY TRONIC CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeHCC  
CFR Regulation Number882.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-02
Decision Date1979-08-28

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