The following data is part of a premarket notification filed by Mark Abramson, D.d.s., Inc with the FDA for Oasys Oral/nasal Airway System And Oasys Herbst With Dentitrac Patient Monitor.
| Device ID | K181571 |
| 510k Number | K181571 |
| Device Name: | OASYS Oral/Nasal Airway System And OASYS Herbst With Dentitrac Patient Monitor |
| Classification | Sleep Appliances With Patient Monitoring |
| Applicant | Mark Abramson, D.D.S., Inc 35 Renato Court Redwood City, CA 94061 |
| Contact | Mark Abramson |
| Correspondent | Cheryl Fisher FisherMed Consulting LLC 820 Civic Center Drive Santa Clara, CA 95050 |
| Product Code | PLC |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-14 |
| Decision Date | 2019-04-19 |