M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ— 510(k) K892355

Substantially Equivalent

Hewlett-Packard Co.

FDA 510(k) clearance K892355 for M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ, Substantially Equivalent on 1989-07-24. Applicant: Hewlett-Packard Co..

Clearance details

Applicant: Hewlett-Packard Co.
Product code: Code IYO
Advisory panel: Radiology
Date received: 1989-04-17
Decision date: 1989-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Germany, DE

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Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.