The following data is part of a premarket notification filed by Entac Medical Inc. with the FDA for Previsea Device.
| Device ID | K211068 |
| 510k Number | K211068 |
| Device Name: | PrevisEA Device |
| Classification | Stethoscope, Electronic |
| Applicant | Entac Medical Inc. 680 Oakleaf Office Lane, Suite 201 Memphis, TN 38117 |
| Contact | Buddy Lyons |
| Correspondent | Adam Harris Target Health LLC 261 Madison Avenue, 24th Floor New York, NY 10016 |
| Product Code | DQD |
| CFR Regulation Number | 870.1875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-12 |
| Decision Date | 2021-08-04 |