NEONATE FLEXFLOAT

Mattress, Water, Temperature Regulated

PHARMAQUEST CORP.

The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Neonate Flexfloat.

Pre-market Notification Details

Device IDK812683
510k NumberK812683
Device Name:NEONATE FLEXFLOAT
ClassificationMattress, Water, Temperature Regulated
Applicant PHARMAQUEST CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFOH  
CFR Regulation Number880.5560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-09-22
Decision Date1981-10-13

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