RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR— 510(k) K934439

Name: FDA 510(k) clearance K934439
Creator: U.S. Food and Drug Administration
Published: 1994-02-17

Substantially Equivalent

Portable Power Systems, Inc.

FDA 510(k) clearance K934439 for RECHARGEABLE BATTERY PACK FOR CRITIKON 8100 VITAL SIGNS MONITOR, Substantially Equivalent on 1994-02-17. Applicant: Portable Power Systems, Inc.. Device class: 2.

Clearance details

Applicant: Portable Power Systems, Inc.
Product code: Code DPS
Device class: Class 2
Regulation: 21 CFR 870.2340
Advisory panel: Cardiovascular
Date received: 1993-08-23
Decision date: 1994-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DPS

product code DPS

Death: 7
Total: 7

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.