The following data is part of a premarket notification filed by Advanced Brain Monitoring Inc. with the FDA for Apnea Risk Evaluation System (ares).
| Device ID | K110705 |
| 510k Number | K110705 |
| Device Name: | APNEA RISK EVALUATION SYSTEM (ARES) |
| Classification | Ventilatory Effort Recorder |
| Applicant | ADVANCED BRAIN MONITORING INC. 2511 FOX RIVER CIRCLE Waukesha, WI 53189 |
| Contact | Adrienne Lenz |
| Correspondent | Adrienne Lenz ADVANCED BRAIN MONITORING INC. 2511 FOX RIVER CIRCLE Waukesha, WI 53189 |
| Product Code | MNR |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-14 |
| Decision Date | 2011-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854485007111 | K110705 | 000 |
| 00854485007104 | K110705 | 000 |
| 00854485007098 | K110705 | 000 |
| 00854485007081 | K110705 | 000 |