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FDA 510(k)

P4-FITNESS

K-Number: K031611 · 2004-09-29

ApplicantValmed Corp.
Decision Date2004-09-29
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

P4-FITNESS is the device name listed in this FDA 510(k) record. The listed applicant is Valmed Corp.. It received FDA 510(k) clearance on 2004-09-29 under 510(k) number K031611. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P4-FITNESS?

P4-FITNESS is a medical device that received FDA 510(k) clearance on 2004-09-29. The listed applicant is Valmed Corp.. The 510(k) number is K031611.

When did P4-FITNESS receive FDA 510(k) clearance?

P4-FITNESS received FDA 510(k) clearance on 2004-09-29, under 510(k) number K031611.

Who is the listed applicant for P4-FITNESS?

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

What is the FDA product code for P4-FITNESS?

The FDA product code for P4-FITNESS is NGX.

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Other records listing Valmed Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K022175P4 PHYSIOK010754NURSE'S ASSISTANT O.R. CONTROL SYSTEMK010716VAL LUX 600 SURGICAL LIGHT (PLUS AND RS), MODEL ML600/S: SINGLE LIGHT HEAD, ML600/SS: SINGLE LIGHT HEAD, ML600/1D): DOUB

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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