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FDA 510(k)

SP NEWTRON MODULE

K-Number: K033764 · 2004-03-01

ApplicantSatelec
Decision Date2004-03-01
Product CodeELC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SP NEWTRON MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2004-03-01 under 510(k) number K033764. 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 SP NEWTRON MODULE?

SP NEWTRON MODULE is a medical device that received FDA 510(k) clearance on 2004-03-01. The listed applicant is Satelec. The 510(k) number is K033764.

When did SP NEWTRON MODULE receive FDA 510(k) clearance?

SP NEWTRON MODULE received FDA 510(k) clearance on 2004-03-01, under 510(k) number K033764.

Who is the listed applicant for SP NEWTRON MODULE?

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 SP NEWTRON MODULE?

The FDA product code for SP NEWTRON MODULE is ELC.

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Related Devices (Code: 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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