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FDA 510(k)

LANDLEX, MODEL P100X

K-Number: K060042 · 2006-02-14

ApplicantBesteam Technology, Inc.
Decision Date2006-02-14
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LANDLEX, MODEL P100X is the device name listed in this FDA 510(k) record. The listed applicant is Besteam Technology, Inc.. It received FDA 510(k) clearance on 2006-02-14 under 510(k) number K060042. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LANDLEX, MODEL P100X?

LANDLEX, MODEL P100X is a medical device that received FDA 510(k) clearance on 2006-02-14. The listed applicant is Besteam Technology, Inc.. The 510(k) number is K060042.

When did LANDLEX, MODEL P100X receive FDA 510(k) clearance?

LANDLEX, MODEL P100X received FDA 510(k) clearance on 2006-02-14, under 510(k) number K060042.

Who is the listed applicant for LANDLEX, MODEL P100X?

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

What is the FDA product code for LANDLEX, MODEL P100X?

The FDA product code for LANDLEX, MODEL P100X is INI.

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 Besteam Technology, 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.

K083303LANDLEX, MODEL: 402XK081980KYMCO FORU, MODEL EQ35K063196LANDLEX, MODEL S403X

Related Devices (Code: INI)

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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