SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR— 510(k) K983355

Substantially Equivalent

Sabratek Corp.

FDA 510(k) clearance K983355 for SABRATEK APM-2000 AMBULATORY PATIENT MONTOR, TRANSCUTANEOUS TEMPERATURE MONITOR, Substantially Equivalent on 1999-03-12. Applicant: Sabratek Corp..

Clearance details

Applicant: Sabratek Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1998-09-23
Decision date: 1999-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.