VERSALET 7700 CARE CENTER, MODEL # 7700— 510(k) K993051

Substantially Equivalent

Hill-Rom Air-Shields

FDA 510(k) clearance K993051 for VERSALET 7700 CARE CENTER, MODEL # 7700, Substantially Equivalent on 2000-02-03. Applicant: Hill-Rom Air-Shields.

Clearance details

Applicant: Hill-Rom Air-Shields
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1999-09-13
Decision date: 2000-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

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Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.