Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042750388

FEI Number

3042750388

Entity Name

METROMED,INC

City/State/Country

Rochester, NY, US

Establishment Address

10 Vantage Point Dr Ste 4, Rochester, NY 14624, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MetroMed,Inc (Owner Number: 10094730)

Owner / Operator Contact Address

10 Vantage Point Drive, Suite 4, Rochester, NY 14624, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

LOLA CPAP HAT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2025-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MetroMed,Inc

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042750388. Last updated year: 2026. Please use registration number 3042750388 when referencing this establishment in official correspondence.