Devices · PeraHealth, Inc.

PeraMobile and PeraWatch

PeraHealth, Inc. is listed for PeraMobile and PeraWatch (K183370). The FDA list gives September 11, 2019 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is MWI. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K183370

Official FDA database record

Date of final decision

September 11, 2019

Company on the FDA list

PeraHealth, Inc.

Lead panel

Cardiovascular

Primary product code

MWI

openFDA device name for the code

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Device class

2

Regulation number

870.2300

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary