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FDA 510(k)

SURPASSON P5 NEWTRON

K-Number: K050895 · 2005-04-20

ApplicantSatelec
Decision Date2005-04-20
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURPASSON P5 NEWTRON is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2005-04-20 under 510(k) number K050895. The device is classified under product code ELC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURPASSON P5 NEWTRON?

SURPASSON P5 NEWTRON is a medical device that received FDA 510(k) clearance on 2005-04-20. The listed applicant is Satelec. The 510(k) number is K050895.

When did SURPASSON P5 NEWTRON receive FDA 510(k) clearance?

SURPASSON P5 NEWTRON received FDA 510(k) clearance on 2005-04-20, under 510(k) number K050895.

Who is the listed applicant for SURPASSON P5 NEWTRON?

The FDA 510(k) record lists Satelec as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURPASSON P5 NEWTRON?

The FDA product code for SURPASSON P5 NEWTRON is ELC.

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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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