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FDA 510(k)

INFINITY MONITORS WITH SCIO MODIFICATIONS

K-Number: K051628 · 2005-07-20

ApplicantDraeger Medical Systems, Inc.
Decision Date2005-07-20
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY MONITORS WITH SCIO MODIFICATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2005-07-20 under 510(k) number K051628. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY MONITORS WITH SCIO MODIFICATIONS?

INFINITY MONITORS WITH SCIO MODIFICATIONS is a medical device that received FDA 510(k) clearance on 2005-07-20. The listed applicant is Draeger Medical Systems, Inc.. The 510(k) number is K051628.

When did INFINITY MONITORS WITH SCIO MODIFICATIONS receive FDA 510(k) clearance?

INFINITY MONITORS WITH SCIO MODIFICATIONS received FDA 510(k) clearance on 2005-07-20, under 510(k) number K051628.

Who is the listed applicant for INFINITY MONITORS WITH SCIO MODIFICATIONS?

The FDA 510(k) record lists Draeger Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFINITY MONITORS WITH SCIO MODIFICATIONS?

The FDA product code for INFINITY MONITORS WITH SCIO MODIFICATIONS is MHX.

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Other records listing Draeger Medical Systems, Inc. as applicant

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Related Devices (Code: MHX)

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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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