TETRA NATAL-MAT WATER FLOTATION MAT.— 510(k) K802833

Substantially Equivalent

Tetra Group U.S.A., Inc.

FDA 510(k) clearance K802833 for TETRA NATAL-MAT WATER FLOTATION MAT., Substantially Equivalent on 1980-12-10. Applicant: Tetra Group U.S.A., Inc..

Clearance details

Applicant: Tetra Group U.S.A., Inc.
Product code: Code IKY
Advisory panel: General Hospital
Date received: 1980-11-12
Decision date: 1980-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code IKY

product code IKY

Death: 5
Malfunction: 491
Other: 4
Total: 500

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.