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FDA 510(k)

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE

K-Number: K093633 · 2010-03-30

ApplicantDraegerwerk AG & CO Kgaa
Decision Date2010-03-30
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE is the device name listed in this FDA 510(k) record. The listed applicant is Draegerwerk AG & CO Kgaa. It received FDA 510(k) clearance on 2010-03-30 under 510(k) number K093633. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE?

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE is a medical device that received FDA 510(k) clearance on 2010-03-30. The listed applicant is Draegerwerk AG & CO Kgaa. The 510(k) number is K093633.

When did INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE receive FDA 510(k) clearance?

INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE received FDA 510(k) clearance on 2010-03-30, under 510(k) number K093633.

Who is the listed applicant for INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE?

The FDA 510(k) record lists Draegerwerk AG & CO Kgaa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE?

The FDA product code for INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE is CBK.

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Related Devices (Code: CBK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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