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FDA 510(k)

SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09

K-Number: K032981 · 2004-04-22

ApplicantInvamed Technologies, Inc.
Decision Date2004-04-22
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 is the device name listed in this FDA 510(k) record. The listed applicant is Invamed Technologies, Inc.. It received FDA 510(k) clearance on 2004-04-22 under 510(k) number K032981. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09?

SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 is a medical device that received FDA 510(k) clearance on 2004-04-22. The listed applicant is Invamed Technologies, Inc.. The 510(k) number is K032981.

When did SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 receive FDA 510(k) clearance?

SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 received FDA 510(k) clearance on 2004-04-22, under 510(k) number K032981.

Who is the listed applicant for SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09?

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

What is the FDA product code for SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09?

The FDA product code for SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09 is BSP.

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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.

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