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Quantum Mini Ventilation Module

by Spectrum Medical Ltd United Kingdom 510(k)

510(k) K210669 Product code DTX

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK210669 Date4 May 2021ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Specification

510(k) · synced 23 Oct 2026

510(k) Number
FDA Product Code
DTX
FDA applicant
Spectrum Medical , Ltd.
Device Class
Class II
Regulation
21 CFR Part 870.4300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Spectrum Medical Ltd

See all devices from Spectrum Medical Ltd →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K210669 24 fields · synced 23 Oct 2026