PULSE/B.P. MONITOR— 510(k) K864411

Substantially Equivalent

Pulse Time Products, Ltd.

FDA 510(k) clearance K864411 for PULSE/B.P. MONITOR, Substantially Equivalent on 1987-06-24. Applicant: Pulse Time Products, Ltd..

Clearance details

Applicant: Pulse Time Products, Ltd.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1986-11-07
Decision date: 1987-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chichester, W. Sussex, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.