Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017398927

FEI Number

3017398927

Entity Name

MY01, INC.

City/State/Country

Montreal Quebec, CA

Establishment Address

400 De Maisonneuve Boulevard West, Suite 700, Montreal Quebec H3A 1L4, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MY01, Inc. (Owner Number: 10061277)

Owner / Operator Contact Address

400 De Maisonneuve Boulevard West, Suite 700, Montreal, CA-QC H3A 1L4, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242997

PMA Number

N/A

All Registered Proprietary Names

MY01 Continuous Compartmental Pressure Monitor MY01 Continuous Compartmental Pressure Monitor MY01 Continuous Compartmental Pressure Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXC	Monitor, Pressure, Intracompartmental	Unknown	Class U	N/A	2022-12-15
LXC	Monitor, Pressure, Intracompartmental	Unknown	Class U	N/A	2021-05-04
LXC	Monitor, Pressure, Intracompartmental	Unknown	Class U	N/A	2025-04-01

Official Correspondent

No official correspondent registered.

US Agent Details

Alan Schwartz Business: mdi Consultants, Inc. Email: info@mdiconsultants.com Phone: (516) 4829001

Related Public Records

Same Entity

MY01, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-06	Stryker Instruments Div. of Stryker Corporation	U	Stryker brand Intra-Compartmental (STIC) Pressure Monitor, Model 295-001-000.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017398927. Last updated year: 2026. Please use registration number 3017398927 when referencing this establishment in official correspondence.