Devices · PeriGen, Inc.

PeriCALM Patterns 3.0

PeriGen, Inc. is listed for PeriCALM Patterns 3.0 (K241009). The FDA list gives January 10, 2025 as the date of the final decision. The lead panel is Obstetrics and Gynecology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is HGM. 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=K241009

Official FDA database record

Date of final decision

January 10, 2025

Company on the FDA list

PeriGen, Inc.

Lead panel

Obstetrics and Gynecology

Primary product code

HGM

openFDA device name for the code

System, Monitoring, Perinatal

Device class

2

Regulation number

884.2740

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary