FDA 510(k)

XCELERA

K-Number: K061995 · 2006-09-06

ApplicantPhilips Medical Systems North America Co.

Decision Date2006-09-06

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

XCELERA is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems North America Co.. It received FDA 510(k) clearance on 2006-09-06 under 510(k) number K061995. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XCELERA?

XCELERA is a medical device that received FDA 510(k) clearance on 2006-09-06. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K061995.

When did XCELERA receive FDA 510(k) clearance?

XCELERA received FDA 510(k) clearance on 2006-09-06, under 510(k) number K061995.

Who is the listed applicant for XCELERA?

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

What is the FDA product code for XCELERA?

The FDA product code for XCELERA is LLZ.

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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.