Identifiers
- 510(k) Number
- K150093 FDA 510(k)
- FDA Product Code
- DQA FDA 510(k)
- Models / Variants
- Pulse Oximeter, Models PC-66A FDA 510(k)PC-66B FDA 510(k)PC-66C FDA 510(k)PC-60B1 FDA 510(k)PC-60B5 FDA 510(k)PC-60D FDA 510(k)PC-60D2 FDA 510(k)PC-60E FDA 510(k)PC-60N FDA 510(k)POD-1 FDA 510(k)POD-2 FDA 510(k)POD-3 FDA 510(k)PC-68A FDA 510(k)PC-68B FDA 510(k)PC-68C FDA 510(k)POD- 1W FDA 510(k)and POD-60NW-1 FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2700 FDA 510(k)
- Regulation Number
- 870.2700 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Pulse Oximeter - POD-3 by Shenzhen Creative Industry Co., Ltd. — Class II — FDA_510K — listed in FDA 510(k) — 17 models — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150093 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Creative Industry Co., Ltd.
Sources (1)
- FDA 510(k) K150093 24 fields · synced Jun 18, 2026