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Device (20-C W +4 more) - Model Hl-3.0 Ob

by Directed Energy, Inc.

510(k) K870841

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 9 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870841 Date2 Feb 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HHR
Models / Variants
Model Hl-3.0 Ob
Device Class
Class II
Regulation
21 CFR Part 884.4550
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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