GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES— 510(k) K972158

Substantially Equivalent

Princeton Regulatory Assoc.

FDA 510(k) clearance K972158 for GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES, Substantially Equivalent on 1998-02-20. Applicant: Princeton Regulatory Assoc..

Clearance details

Applicant: Princeton Regulatory Assoc.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 1997-06-09
Decision date: 1998-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Princeton, NJ, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.