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FDA 510(k)

SmartPerfusion

K-Number: K181966 · 2018-08-17

ApplicantPhilips Medical Systems Nederlands B.V.
Decision Date2018-08-17
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SmartPerfusion is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederlands B.V.. It received FDA 510(k) clearance on 2018-08-17 under 510(k) number K181966. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmartPerfusion?

SmartPerfusion is a medical device that received FDA 510(k) clearance on 2018-08-17. The listed applicant is Philips Medical Systems Nederlands B.V.. The 510(k) number is K181966.

When did SmartPerfusion receive FDA 510(k) clearance?

SmartPerfusion received FDA 510(k) clearance on 2018-08-17, under 510(k) number K181966.

Who is the listed applicant for SmartPerfusion?

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

What is the FDA product code for SmartPerfusion?

The FDA product code for SmartPerfusion is OWB.

Other records listing Philips Medical Systems Nederlands B.V. as applicant

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Related Devices (Code: OWB)

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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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