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ANNE One

by Sibel, Inc. 510(k)

Active United States

510(k) K211305

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211305 Date14 Sep 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  • Withdrawn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
DRG
Device Class
Class II
Regulation
21 CFR Part 870.2910
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Sibel, Inc.

  • ANNE Pediatric

    Class II

  • ANNE Sleep

    Class II