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Cardiocap Dr-124 Recorder

by Datex Division Instrumentarium Corp. 510(k)

Active United States

510(k) K910620

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910620 Date7 May 1991ClearedStatusActive

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  • Withdrawn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

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