PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P— 510(k) K083351

Substantially Equivalent

Comdek Industrial Corp.

FDA 510(k) clearance K083351 for PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P, Substantially Equivalent on 2009-04-24. Applicant: Comdek Industrial Corp..

Clearance details

Applicant: Comdek Industrial Corp.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2008-11-13
Decision date: 2009-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.