PRESSURE INFUSOR— 510(k) K881977

Substantially Equivalent

Primrose Medical, Inc.

FDA 510(k) clearance K881977 for PRESSURE INFUSOR, Substantially Equivalent on 1988-07-29. Applicant: Primrose Medical, Inc..

Clearance details

Applicant: Primrose Medical, Inc.
Product code: Code KZD
Advisory panel: General Hospital
Date received: 1988-05-11
Decision date: 1988-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

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Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

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.