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FDA 510(k)

NARKOMED MRI-2, MODEL NM-MRI-2

K-Number: K003579 · 2001-01-22

ApplicantDraeger Medical, Inc.
Decision Date2001-01-22
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NARKOMED MRI-2, MODEL NM-MRI-2 is the device name listed in this FDA 510(k) record. The listed applicant is Draeger Medical, Inc.. It received FDA 510(k) clearance on 2001-01-22 under 510(k) number K003579. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NARKOMED MRI-2, MODEL NM-MRI-2?

NARKOMED MRI-2, MODEL NM-MRI-2 is a medical device that received FDA 510(k) clearance on 2001-01-22. The listed applicant is Draeger Medical, Inc.. The 510(k) number is K003579.

When did NARKOMED MRI-2, MODEL NM-MRI-2 receive FDA 510(k) clearance?

NARKOMED MRI-2, MODEL NM-MRI-2 received FDA 510(k) clearance on 2001-01-22, under 510(k) number K003579.

Who is the listed applicant for NARKOMED MRI-2, MODEL NM-MRI-2?

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

What is the FDA product code for NARKOMED MRI-2, MODEL NM-MRI-2?

The FDA product code for NARKOMED MRI-2, MODEL NM-MRI-2 is BSZ.

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Other records listing Draeger Medical, Inc. as applicant

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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Related Devices (Code: BSZ)

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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