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DEKA ACE Pump System

by Deka Research and Development 510(k)

Active United States

510(k) K241178

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK241178 Date24 May 2024ClearedStatusActive

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  • Withdrawn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
QFG
Device Class
Class II
Regulation
21 CFR Part 880.5730
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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