# Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
> **Product code: KLK** · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.2500
## Classification
- **FDA Product Code:** KLK
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 868.2500
- **Review panel:** AN
- **Medical specialty:** Anesthesiology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Market data
- **Cleared 510(k) submissions:** 47
- **Registered establishments:** 17
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=KLK)
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