DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE— 510(k) K945729

Substantially Equivalent

Hill-Rom, Inc.

FDA 510(k) clearance K945729 for DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE, Substantially Equivalent on 1995-02-27. Applicant: Hill-Rom, Inc..

Clearance details

Applicant: Hill-Rom, Inc.
Product code: Code IOQ
Advisory panel: Physical Medicine
Date received: 1994-11-22
Decision date: 1995-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Batesville, IN, US

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Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.