Regulora

Computerized Behavioral Therapy Device For Treating Symptoms

MetaMe Health, Inc.

The following data is part of a premarket notification filed by Metame Health, Inc. with the FDA for Regulora.

Pre-market Notification Details

Device IDK211463
510k NumberK211463
Device Name:Regulora
ClassificationComputerized Behavioral Therapy Device For Treating Symptoms
Applicant metaMe Health, Inc. 222 W. Merchandise Mart Plaza - Suite 1230 Chicago,  IL  60654
ContactTim Rudolphi
CorrespondentNandini Murthy
metaMe Health, Inc. 222 W. Merchandise Mart Plaza - Suite 1230 Chicago,  IL  60654
Product CodeQMY  
CFR Regulation Number876.5960 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-11
Decision Date2021-11-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860005970209 K211463 000

Trademark Results [Regulora]

Mark Image

Registration | Serial
Company
Trademark
Application Date
REGULORA
REGULORA
87801516 not registered Live/Pending
Metame Health, Inc.
2018-02-16

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