The following data is part of a premarket notification filed by Watermark Medical with the FDA for Apnea Risk Evaluation System (ares), Model 620.
| Device ID | K160499 |
| 510k Number | K160499 |
| Device Name: | Apnea Risk Evaluation System (ARES), Model 620 |
| Classification | Ventilatory Effort Recorder |
| Applicant | Watermark Medical 1641 Worthington Road, Suite 320 West Palm Beach, FL 33409 |
| Contact | Frank Katarow |
| Correspondent | Michael Leigh Michael Leigh 19019 W. Coffee Road New Berlin, WI 53146 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-23 |
| Decision Date | 2017-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854485007180 | K160499 | 000 |
| 00854485007012 | K160499 | 000 |
| 00854485007036 | K160499 | 000 |
| 00854485007043 | K160499 | 000 |
| 00854485007050 | K160499 | 000 |
| 00854485007067 | K160499 | 000 |
| 00854485007074 | K160499 | 000 |
| 00854485007166 | K160499 | 000 |
| 00854485007173 | K160499 | 000 |
| 00854485007005 | K160499 | 000 |