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FDA 510(k)

MINIFLEX AND PERSONAL UNIT

K-Number: K912997 · 1991-10-30

ApplicantDabi-Atlante America Corp.
Decision Date1991-10-30
Product CodeEAZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINIFLEX AND PERSONAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Dabi-Atlante America Corp.. It received FDA 510(k) clearance on 1991-10-30 under 510(k) number K912997. The device is classified under product code EAZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINIFLEX AND PERSONAL UNIT?

MINIFLEX AND PERSONAL UNIT is a medical device that received FDA 510(k) clearance on 1991-10-30. The listed applicant is Dabi-Atlante America Corp.. The 510(k) number is K912997.

When did MINIFLEX AND PERSONAL UNIT receive FDA 510(k) clearance?

MINIFLEX AND PERSONAL UNIT received FDA 510(k) clearance on 1991-10-30, under 510(k) number K912997.

Who is the listed applicant for MINIFLEX AND PERSONAL UNIT?

The FDA 510(k) record lists Dabi-Atlante America Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MINIFLEX AND PERSONAL UNIT?

The FDA product code for MINIFLEX AND PERSONAL UNIT is EAZ.

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Other records listing Dabi-Atlante America Corp. as applicant

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Related Devices (Code: EAZ)

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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