PS SYSTEM WITH SD-200 DOPPLER— 510(k) K861358

Substantially Equivalent for Some Indications

Johnson & Johnson Professionals, Inc.

FDA 510(k) clearance K861358 for PS SYSTEM WITH SD-200 DOPPLER, Substantially Equivalent for Some Indications on 1986-07-30. Applicant: Johnson & Johnson Professionals, Inc..

Clearance details

Applicant: Johnson & Johnson Professionals, Inc.
Product code: Code ITX
Advisory panel: Radiology
Date received: 1986-04-10
Decision date: 1986-07-30
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Ramsey, NJ, US

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Adverse events under product code ITX

product code ITX

Death: 6
Injury: 137
Malfunction: 2,036
Total: 2,179

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.