The following data is part of a premarket notification filed by Invoy Technologies, Llc with the FDA for Anascient Breath Monitor.
| Device ID | K110810 |
| 510k Number | K110810 |
| Device Name: | ANASCIENT BREATH MONITOR |
| Classification | Computer, Oxygen-uptake |
| Applicant | INVOY TECHNOLOGIES, LLC 1820 E.RAY ROAD Chandler, AZ 85225 |
| Contact | Lubna M Ahmad |
| Correspondent | Bhavesh V Sheth INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-03-23 |
| Decision Date | 2011-06-21 |