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FDA 510(k)

STEROTACTIC LOCALIZATION DEVICE (SLD)

K-Number: K000832 · 2000-04-27

ApplicantPhilips Medical Systems North America, Inc.
Decision Date2000-04-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STEROTACTIC LOCALIZATION DEVICE (SLD) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America, Inc.. It received FDA 510(k) clearance on 2000-04-27 under 510(k) number K000832. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEROTACTIC LOCALIZATION DEVICE (SLD)?

STEROTACTIC LOCALIZATION DEVICE (SLD) is a medical device that received FDA 510(k) clearance on 2000-04-27. The listed applicant is Philips Medical Systems North America, Inc.. The 510(k) number is K000832.

When did STEROTACTIC LOCALIZATION DEVICE (SLD) receive FDA 510(k) clearance?

STEROTACTIC LOCALIZATION DEVICE (SLD) received FDA 510(k) clearance on 2000-04-27, under 510(k) number K000832.

Who is the listed applicant for STEROTACTIC LOCALIZATION DEVICE (SLD)?

The FDA 510(k) record lists Philips Medical Systems North America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STEROTACTIC LOCALIZATION DEVICE (SLD)?

The FDA product code for STEROTACTIC LOCALIZATION DEVICE (SLD) is LNH.

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Other records listing Philips Medical Systems North America, 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.

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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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