Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1— 510(k) K150093

Substantially Equivalent

Shenzhen Creative Industry Co., Ltd.

FDA 510(k) clearance K150093 for Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1, Substantially Equivalent on 2015-06-03. Applicant: Shenzhen Creative Industry Co., Ltd..

Clearance details

Applicant: Shenzhen Creative Industry Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2015-01-16
Decision date: 2015-06-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen City, CN

Download summary PDF View on FDA.gov ↗

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.