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FDA 510(k)

SENTRYSUITE PRODUCT LINE

K-Number: K122699 · 2012-11-19

ApplicantCarefusion Germany 234 GmbH
Decision Date2012-11-19
Product CodeBTY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SENTRYSUITE PRODUCT LINE is the device name listed in this FDA 510(k) record. The listed applicant is Carefusion Germany 234 GmbH. It received FDA 510(k) clearance on 2012-11-19 under 510(k) number K122699. The device is classified under product code BTY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENTRYSUITE PRODUCT LINE?

SENTRYSUITE PRODUCT LINE is a medical device that received FDA 510(k) clearance on 2012-11-19. The listed applicant is Carefusion Germany 234 GmbH. The 510(k) number is K122699.

When did SENTRYSUITE PRODUCT LINE receive FDA 510(k) clearance?

SENTRYSUITE PRODUCT LINE received FDA 510(k) clearance on 2012-11-19, under 510(k) number K122699.

Who is the listed applicant for SENTRYSUITE PRODUCT LINE?

The FDA 510(k) record lists Carefusion Germany 234 GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENTRYSUITE PRODUCT LINE?

The FDA product code for SENTRYSUITE PRODUCT LINE is BTY.

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Other records listing Carefusion Germany 234 GmbH as applicant

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Related Devices (Code: BTY)

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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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