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FDA 510(k)

MultiBand SENSE

K-Number: K162940 · 2016-12-30

Decision Date2016-12-30
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MultiBand SENSE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-12-30 under 510(k) number K162940. 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 MultiBand SENSE?

MultiBand SENSE is a medical device that received FDA 510(k) clearance on 2016-12-30. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K162940.

When did MultiBand SENSE receive FDA 510(k) clearance?

MultiBand SENSE received FDA 510(k) clearance on 2016-12-30, under 510(k) number K162940.

Who is the listed applicant for MultiBand SENSE?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MultiBand SENSE?

The FDA product code for MultiBand SENSE is LNH.

Other records listing Philips Medical Systems Nederland B.V. 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.

View all 79 devices →

Related Devices (Code: LNH)

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.

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.