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FDA 510(k)

cobas pulse blood glucose monitoring system

K-Number: K220272 · 2024-04-26

ApplicantRoche Diagnostics
Decision Date2024-04-26
Product CodePZI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

cobas pulse blood glucose monitoring system is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2024-04-26 under approval number K220272. The device is classified under product code PZI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas pulse blood glucose monitoring system?

cobas pulse blood glucose monitoring system is a medical device that received FDA 510(k) clearance on 2024-04-26. It is manufactured by Roche Diagnostics. The 510(k) number is K220272.

When was cobas pulse blood glucose monitoring system approved by the FDA?

cobas pulse blood glucose monitoring system received FDA 510(k) clearance on 2024-04-26, under approval number K220272.

What company makes cobas pulse blood glucose monitoring system?

cobas pulse blood glucose monitoring system is manufactured by Roche Diagnostics.

What is the FDA product code for cobas pulse blood glucose monitoring system?

The FDA product code for cobas pulse blood glucose monitoring system is PZI.

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Related PubMed Literature

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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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