Data / Medical devices / United States / WATERMARK MEDICAL Inc
WATERMARK MEDICAL Inc: FDA-registered device maker in Atlanta, GA, United States, 4 510(k) clearances
WATERMARK MEDICAL Inc is registered with the FDA (registration 3008208119) in Atlanta, GA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated April 24, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008208119
- Address
- 1117 Perimeter Ctr W Suite W514, Atlanta, GA, United States, 30338
- Owner or operator
- Watermark Medical Inc. (10030156)
- Roles
- Specification developer
- First device listed
- July 24, 2012
- Registered through
- 2026
- Brand names listed
- Apnea Risk Evaluation system Ares 610, Apnea Risk Evaluation system Ares 620, Ventilatory Effort Recorder (Ares 610 with belt), Ventilatory Effort Recorder (Ares 610), Ventilatory Effort Recorder (Ares 620 added Web Based SW)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ventilatory Effort Recorder | MNR | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 24, 2017 | K160499 | Apnea Risk Evaluation System (ARES), Model 620 | MNR | Substantially Equivalent | Watermark Medical | accessdata.fda.gov |
| January 9, 2012 | K112514 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | Substantially Equivalent | Advanced Brain Monitoring, Inc. | accessdata.fda.gov |
| July 7, 2011 | K111194 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | Substantially Equivalent | Advanced Brain Monitoring, Inc. | accessdata.fda.gov |
| April 14, 2011 | K110705 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | Substantially Equivalent | Advanced Brain Monitoring, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 24, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.