FDA 510(k)

DENPAX

K-Number: K860058 · 1986-03-12

Decision Date1986-03-12

Product CodeEBR

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DENPAX is the device name listed in this FDA 510(k) record. The listed applicant is Nissho Iwai American Corp.. It received FDA 510(k) clearance on 1986-03-12 under 510(k) number K860058. The device is classified under product code EBR. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENPAX?

DENPAX is a medical device that received FDA 510(k) clearance on 1986-03-12. The listed applicant is Nissho Iwai American Corp.. The 510(k) number is K860058.

When did DENPAX receive FDA 510(k) clearance?

DENPAX received FDA 510(k) clearance on 1986-03-12, under 510(k) number K860058.

Who is the listed applicant for DENPAX?

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

What is the FDA product code for DENPAX?

The FDA product code for DENPAX is EBR.

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Related Devices (Code: EBR)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.