Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008208119

FEI Number

3008208119

Entity Name

WATERMARK MEDICAL Inc

City/State/Country

Atlanta, GA, US

Establishment Address

1117 Perimeter Ctr W Suite W514, Atlanta, GA 30338, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Watermark Medical Inc. (Owner Number: 10030156)

Owner / Operator Contact Address

1117 Perimeter Center West, Suite W514, Atlanta, GA 30338, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K110705

PMA Number

N/A

All Registered Proprietary Names

Apnea Risk Evaluation system Ares 610 Ventilatory Effort Recorder (Ares 620 added Web Based SW) Ventilatory Effort Recorder (Ares 610 with belt) Ventilatory Effort Recorder (Ares 610)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2012-07-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2012-07-24
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2012-07-24

Official Correspondent

Bayan Saleh

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Watermark Medical Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008208119. Last updated year: 2026. Please use registration number 3008208119 when referencing this establishment in official correspondence.