The following data is part of a premarket notification filed by Microdental, Inc. with the FDA for Micro2 Osa Device With Micro-recorder.
| Device ID | K161624 |
| 510k Number | K161624 |
| Device Name: | MicrO2 OSA Device With Micro-Recorder |
| Classification | Sleep Appliances With Patient Monitoring |
| Applicant | MICRODENTAL, Inc. 5601 Arnold Rd. Dublin, CA 94568 |
| Contact | David Kuhns |
| Correspondent | David Kuhns MICRODENTAL, Inc. 5601 Arnold Rd. Dublin, CA 94568 |
| Product Code | PLC |
| CFR Regulation Number | 872.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2016-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863039000430 | K161624 | 000 |