PULSE TIME PRODUCTS LIMITED, PM-3— 510(k) K892795

Substantially Equivalent

Pulse Time Products, Ltd.

FDA 510(k) clearance K892795 for PULSE TIME PRODUCTS LIMITED, PM-3, Substantially Equivalent on 1989-08-25. Applicant: Pulse Time Products, Ltd..

Clearance details

Applicant: Pulse Time Products, Ltd.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1989-04-17
Decision date: 1989-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chichester, W. Sussex, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

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.