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FDA 510(k)

ACHIEVA FAMILY

K-Number: K043147 · 2005-02-15

ApplicantPhilips Medical Systems North America Co.
Decision Date2005-02-15
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACHIEVA FAMILY 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 2005-02-15 under 510(k) number K043147. 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 ACHIEVA FAMILY?

ACHIEVA FAMILY is a medical device that received FDA 510(k) clearance on 2005-02-15. The listed applicant is Philips Medical Systems North America Co.. The 510(k) number is K043147.

When did ACHIEVA FAMILY receive FDA 510(k) clearance?

ACHIEVA FAMILY received FDA 510(k) clearance on 2005-02-15, under 510(k) number K043147.

Who is the listed applicant for ACHIEVA FAMILY?

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 ACHIEVA FAMILY?

The FDA product code for ACHIEVA FAMILY is LNH.

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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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