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FDA 510(k)

ABBOTT INPERSOL CYCLER 1000

K-Number: K895336 · 1989-11-28

ApplicantAbbott Laboratories
Decision Date1989-11-28
Product CodeFKX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ABBOTT INPERSOL CYCLER 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1989-11-28 under 510(k) number K895336. The device is classified under product code FKX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABBOTT INPERSOL CYCLER 1000?

ABBOTT INPERSOL CYCLER 1000 is a medical device that received FDA 510(k) clearance on 1989-11-28. The listed applicant is Abbott Laboratories. The 510(k) number is K895336.

When did ABBOTT INPERSOL CYCLER 1000 receive FDA 510(k) clearance?

ABBOTT INPERSOL CYCLER 1000 received FDA 510(k) clearance on 1989-11-28, under 510(k) number K895336.

Who is the listed applicant for ABBOTT INPERSOL CYCLER 1000?

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 INPERSOL CYCLER 1000?

The FDA product code for ABBOTT INPERSOL CYCLER 1000 is FKX.

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Related Devices (Code: FKX)

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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