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FDA 510(k)

MIE FALCON, DATEX ENGSTROM FLEXIMA II

K-Number: K971030 · 1997-11-12

ApplicantMedical and Industrial Equipment
Decision Date1997-11-12
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MIE FALCON, DATEX ENGSTROM FLEXIMA II is the device name listed in this FDA 510(k) record. The listed applicant is Medical and Industrial Equipment. It received FDA 510(k) clearance on 1997-11-12 under 510(k) number K971030. 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 MIE FALCON, DATEX ENGSTROM FLEXIMA II?

MIE FALCON, DATEX ENGSTROM FLEXIMA II is a medical device that received FDA 510(k) clearance on 1997-11-12. The listed applicant is Medical and Industrial Equipment. The 510(k) number is K971030.

When did MIE FALCON, DATEX ENGSTROM FLEXIMA II receive FDA 510(k) clearance?

MIE FALCON, DATEX ENGSTROM FLEXIMA II received FDA 510(k) clearance on 1997-11-12, under 510(k) number K971030.

Who is the listed applicant for MIE FALCON, DATEX ENGSTROM FLEXIMA II?

The FDA 510(k) record lists Medical and Industrial Equipment as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MIE FALCON, DATEX ENGSTROM FLEXIMA II?

The FDA product code for MIE FALCON, DATEX ENGSTROM FLEXIMA II is BSZ.

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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

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

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