DeviceClearance

PULSE-AID DEVICE— 510(k) K843977

Substantially Equivalent

James J. Lally

FDA 510(k) clearance K843977 for PULSE-AID DEVICE, Substantially Equivalent on 1985-02-01. Applicant: James J. Lally.

Clearance details

Applicant
James J. Lally
Product code
Code LIX
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Kansas City, MO, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LIX

product code LIX
Other
2
Total
2

Source: openFDA MAUDE database, through . 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.