Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Instruments for Cardiac Research with 8 510(k) clearances. The most recent is a 510(k) clearance dated Apr 17, 1984: HOLTER CARDIOGRAPHY SYS 6201.
| Apr 17, 1984 | HOLTER CARDIOGRAPHY SYS 6201K834397 · DSI | 510(k) clearances |
| May 18, 1982 | EVENTMASTER 3 HOLTER EVENT SCANNERK821173 · DSF | 510(k) clearances |
| Apr 29, 1982 | EVENTMASTER 2K820856 · DSI | 510(k) clearances |
| Jan 22, 1982 | CARDIOSTRESSK820011 · DPS | 510(k) clearances |
| Dec 2, 1981 | EVENT MASTERK812920 · DSH | 510(k) clearances |
| Mar 11, 1981 | SERIES 4000 STRESS & EXERCISE SYSTEMK801903 · DSI | 510(k) clearances |
| Aug 4, 1977 | SCANNER TREND SYSTEMK771374 · DSI | 510(k) clearances |
| Jun 2, 1977 | CARDIAC ACQUISITION SYSTEM, ICR 2001K770705 · DQK | 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
