Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled 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 14, 2026, FDA's public records list Sabratek with 7 510(k) clearances. The most recent is a 510(k) clearance dated Mar 12, 1999: SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR.
| Mar 12, 1999 | SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITORK983355 · FLL | 510(k) clearances |
| Feb 24, 1999 | SABRATEK 4040 INFUSION PUMPK980751 · FRN | 510(k) clearances |
| Aug 20, 1998 | SABRATEK PATIENT HOME MANAGEMENT SYSTEMK980619 · MHX | 510(k) clearances |
| Jun 3, 1996 | 3030 INFUSION PUMPK955258 · FRN | 510(k) clearances |
| Mar 23, 1995 | SABRATEK SABSIL SETSK944293 · FPA | 510(k) clearances |
| Jul 19, 1994 | SABRATEK 6060 HOMERUN VOLUMETRIC INFUSION PUMPK941984 · FRN | 510(k) clearances |
| May 18, 1992 | SABRATEK 3030 INFUSION PUMPK914589 · FRN | 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
