ISOLETTE INCUBATOR— 510(k) K781876

Substantially Equivalent

Air-Shields, Inc.

FDA 510(k) clearance K781876 for ISOLETTE INCUBATOR, Substantially Equivalent on 1978-12-07. Applicant: Air-Shields, Inc..

Clearance details

Applicant: Air-Shields, Inc.
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1978-11-02
Decision date: 1978-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.