VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE— 510(k) K900451

Name: FDA 510(k) clearance K900451
Creator: U.S. Food and Drug Administration
Published: 1990-07-18

Substantially Equivalent

Pace Tech, Inc.

FDA 510(k) clearance K900451 for VITALMAX 800 NON-INVASIVE VITAL SIGN MONITOR/PULSE, Substantially Equivalent on 1990-07-18. Applicant: Pace Tech, Inc.. Device class: 2.

Clearance details

Applicant: Pace Tech, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1990-01-30
Decision date: 1990-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Pace Tech, Inc.

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K951226 — VITALMAX 4000/MINIPACK 3100/30001996-11-21
K953795 — VITALMAX 41001996-07-01
K944541 — HANDYPACK 911SC1995-02-22
K945385 — VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 3001995-01-31
K925701 — MINIPACK 911-STC1994-08-11

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.