Advanced Brain Monitoring, Inc.
Carlsbad, CA, US
ADVANCED BRAIN MONITORING, INC. appears in FDA device records in Carlsbad, CA. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Advanced Brain Monitoring, Inc. between 2004 and 2018. The busiest year on record is 2011, with 3. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2004 | 1 |
| 2007 | 1 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 3 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172799 | Positional Sleep Assessment System (PoSAS) software | MNR | Substantially Equivalent | |
| K153412 | Sleep Profiler | OLZ | Substantially Equivalent | |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | OMC | Substantially Equivalent | |
| K140190 | NIGHT SHIFT | MYB | Substantially Equivalent | |
| K131383 | X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE | GWQ | Substantially Equivalent | |
| K130007 | SLEEP PROFILER | OLZ | Substantially Equivalent | |
| K130013 | X4 SYSTEM | OMC | Substantially Equivalent | |
| K120450 | SLEEP PROFILER | OLZ | Substantially Equivalent | |
| K120447 | X4 | OMC | Substantially Equivalent | |
| K112514 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | Substantially Equivalent | |
| K111110 | APNEA GUARD | LRK | Substantially Equivalent | |
| K111194 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | Substantially Equivalent | |
| K110705 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | Substantially Equivalent | |
| K071230 | APNEA RISK EVALUATION SYSTEM (ARES), MODEL 600 | MNR | Substantially Equivalent | |
| K041662 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004964738 | 3004964738 | ADVANCED BRAIN MONITORING, INC. | 2237 FARADAY AVE STE 100, CARLSBAD, CA 92008 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OLZAutomatic Event Detection Software For Polysomnograph With Electroencephalograph
- LRKDevice, Anti-Snoring
- GWQFull-Montage Standard Electroencephalograph
- MYBPillow, Cervical (For Mild Sleep Apnea)
- OMCReduced- Montage Standard Electroencephalograph
- OLVStandard Polysomnograph With Electroencephalograph
- MNRVentilatory Effort Recorder
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain