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FDA 510(k)

epoc Blood Analysis System

K-Number: K200107 · 2020-06-05

ApplicantEpocal, Inc.
Decision Date2020-06-05
Product CodeCHL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

epoc Blood Analysis System is a medical device manufactured by Epocal, Inc.. It received FDA 510(k) clearance on 2020-06-05 under approval number K200107. The device is classified under product code CHL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the epoc Blood Analysis System?

epoc Blood Analysis System is a medical device that received FDA 510(k) clearance on 2020-06-05. It is manufactured by Epocal, Inc.. The 510(k) number is K200107.

When was epoc Blood Analysis System approved by the FDA?

epoc Blood Analysis System received FDA 510(k) clearance on 2020-06-05, under approval number K200107.

What company makes epoc Blood Analysis System?

epoc Blood Analysis System is manufactured by Epocal, Inc..

What is the FDA product code for epoc Blood Analysis System?

The FDA product code for epoc Blood Analysis System is CHL.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Epocal, Inc.

K171247epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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