← Product Code [KLK](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK) · K840919 # DAYPAK SYS VII CATHETER CARE KIT (K840919) _Creative Care Systems, Inc. · KLK · Apr 17, 1984 · Anesthesiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K840919 ## Device Facts - **Applicant:** Creative Care Systems, Inc. - **Product Code:** [KLK](/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK.md) - **Decision Date:** Apr 17, 1984 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 868.2500 - **Device Class:** Class 2 - **Review Panel:** Anesthesiology ## Regulatory Identification A cutaneous oxygen (PcO2) monitor is a noninvasive, heated sensor (e.g., a Clark-type polargraphic electrode) placed on the patient's skin that is intended to monitor relative changes in the cutaneous oxygen tension. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9. The special control is FDA's “Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide (PcCO2) and Oxygen (PcO2) Monitors; Guidance for Industry and FDA.” See § 868.1(e) for the availability of this guidance document. --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K840919](https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K840919) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/AN/subpart-c%E2%80%94monitoring-devices/KLK/K840919