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PrevisEA Device

by Entac Medical, Inc. 510(k)

Active United States

510(k) K211068

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211068 Date4 Aug 2021ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQD
Device Class
Class II
Regulation
21 CFR Part 870.1875
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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