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FDA 510(k)

ABBOTT AXSYM SYSTEM

K-Number: K974651 · 1998-02-12

ApplicantAbbott Laboratories
Decision Date1998-02-12
Product CodeJJE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT AXSYM SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-02-12 under 510(k) number K974651. The device is classified under product code JJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT AXSYM SYSTEM?

ABBOTT AXSYM SYSTEM is a medical device that received FDA 510(k) clearance on 1998-02-12. The listed applicant is Abbott Laboratories. The 510(k) number is K974651.

When did ABBOTT AXSYM SYSTEM receive FDA 510(k) clearance?

ABBOTT AXSYM SYSTEM received FDA 510(k) clearance on 1998-02-12, under 510(k) number K974651.

Who is the listed applicant for ABBOTT AXSYM SYSTEM?

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

What is the FDA product code for ABBOTT AXSYM SYSTEM?

The FDA product code for ABBOTT AXSYM SYSTEM is JJE.

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Related Devices (Code: JJE)

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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