MAMM-AIRE

Cradle, Patient, Radiologic

AR CUSTOM MEDICAL PRODUCTS, LTD.

The following data is part of a premarket notification filed by Ar Custom Medical Products, Ltd. with the FDA for Mamm-aire.

Pre-market Notification Details

Device IDK863890
510k NumberK863890
Device Name:MAMM-AIRE
ClassificationCradle, Patient, Radiologic
Applicant AR CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park,  NY  11729
ContactJames Collette
CorrespondentJames Collette
AR CUSTOM MEDICAL PRODUCTS, LTD. 19A WEST INDUSTRY COURT Deer Park,  NY  11729
Product CodeKXH  
CFR Regulation Number892.1830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-10-06
Decision Date1986-10-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850306007599 K863890 000
00850306007582 K863890 000
00850306007575 K863890 000
00850306007551 K863890 000
00850306007544 K863890 000
00850306007537 K863890 000
00850306007605 K863890 000

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