Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Applied Cardiac Systems, Inc. with 5 510(k) clearances. The most recent is a 510(k) clearance dated Aug 24, 2011: THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR.
| Aug 24, 2011 | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITORK103706 · QYX | 510(k) clearances |
| Dec 9, 2004 | ACS MODEL NCP-2K042413 · DRN | 510(k) clearances |
| Mar 11, 1986 | THE HOLTER REPORTER (TM)K860249 · DPS | 510(k) clearances |
| Dec 1, 1983 | HOLTER PERFORMER FEATHER WEIGHT/CASSK833823 · DSH | 510(k) clearances |
| Jan 29, 1982 | HOLTER PERFORMERK813602 · DSH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
