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

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..

Clearance details

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

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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.