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EBS2605 Infant Hugger

by Equilibrated Bio Systems, Inc. 510(k)

Active United States

510(k) K892705

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK892705 Date27 Oct 1989ClearedStatusActive

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  • Withdrawn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 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
BTY
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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