TEMPO III— 510(k) K981509

Name: FDA 510(k) clearance K981509
Creator: U.S. Food and Drug Administration
Published: 1998-07-10

Substantially Equivalent

Medical Products, Inc.

FDA 510(k) clearance K981509 for TEMPO III, Substantially Equivalent on 1998-07-10. Applicant: Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Medical Products, Inc.
Product code: Code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 1998-04-28
Decision date: 1998-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chantilly, VA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

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.