FDA 510(k)

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE

K-Number: K093632 · 2010-04-05

Decision Date2010-04-05

Product CodeCBK

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE is the device name listed in this FDA 510(k) record. The listed applicant is Drager Medical AG & Co. Kgaa. It received FDA 510(k) clearance on 2010-04-05 under 510(k) number K093632. 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 NEONATAL CARE?

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE is a medical device that received FDA 510(k) clearance on 2010-04-05. The listed applicant is Drager Medical AG & Co. Kgaa. The 510(k) number is K093632.

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

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE received FDA 510(k) clearance on 2010-04-05, under 510(k) number K093632.

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

The FDA 510(k) record lists Drager Medical 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 NEONATAL CARE?

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

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Official Source

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