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FDA 510(k)

EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)

K-Number: K892227 · 1989-06-20

ApplicantEdentec Corp.
Decision Date1989-06-20
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) is the device name listed in this FDA 510(k) record. The listed applicant is Edentec Corp.. It received FDA 510(k) clearance on 1989-06-20 under 510(k) number K892227. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)?

EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) is a medical device that received FDA 510(k) clearance on 1989-06-20. The listed applicant is Edentec Corp.. The 510(k) number is K892227.

When did EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) receive FDA 510(k) clearance?

EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) received FDA 510(k) clearance on 1989-06-20, under 510(k) number K892227.

Who is the listed applicant for EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)?

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

What is the FDA product code for EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU)?

The FDA product code for EDENTEC MODEL 2001 MODULAR MEMORY UNIT (MMU) is DSH.

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Other records listing Edentec Corp. as applicant

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Related Devices (Code: DSH)

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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