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

Name: FDA 510(k) clearance K892795
Creator: U.S. Food and Drug Administration
Published: 1989-08-25

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.. Device class: 2.

Clearance details

Applicant: Pulse Time Products, Ltd.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
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 ↗

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More clearances from Pulse Time Products, Ltd.

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K901392 — BP50 BLOOD PRESSURE AND PULSE MONITOR1990-08-23
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K864411 — PULSE/B.P. MONITOR1987-06-24
K864748 — PM-8 HEART RATE MONITOR1987-03-20
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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.