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FDA 510(k)

PULSERA

K-Number: K061685 · 2006-09-15

ApplicantPhilips Medical Systems North America Co.
Decision Date2006-09-15
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PULSERA 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 2006-09-15 under 510(k) number K061685. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSERA?

PULSERA is a medical device that received FDA 510(k) clearance on 2006-09-15. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K061685.

When did PULSERA receive FDA 510(k) clearance?

PULSERA received FDA 510(k) clearance on 2006-09-15, under 510(k) number K061685.

Who is the listed applicant for PULSERA?

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 PULSERA?

The FDA product code for PULSERA is IZL.

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Related Devices (Code: IZL)

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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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