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FDA 510(k)

AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000

K-Number: K981423 · 1998-05-20

ApplicantAutogenesis, Inc.
Decision Date1998-05-20
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 is the device name listed in this FDA 510(k) record. The listed applicant is Autogenesis, Inc.. It received FDA 510(k) clearance on 1998-05-20 under 510(k) number K981423. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000?

AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 is a medical device that received FDA 510(k) clearance on 1998-05-20. The listed applicant is Autogenesis, Inc.. The 510(k) number is K981423.

When did AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 receive FDA 510(k) clearance?

AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 received FDA 510(k) clearance on 1998-05-20, under 510(k) number K981423.

Who is the listed applicant for AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000?

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

What is the FDA product code for AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000?

The FDA product code for AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000 is JEC.

Related Clinical Trials

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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Other records listing Autogenesis, 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.

K013818AUTOGENESIS AUTOMATOR, MODEL M1000

Related Devices (Code: JEC)

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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