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FDA 510(k)

RAPID PROGRAMMER, VERSION 3.3.0

K-Number: K091993 · 2009-07-31

ApplicantAdvanced Neuromodulation Systems, Inc. (Ans Inc.)
Decision Date2009-07-31
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RAPID PROGRAMMER, VERSION 3.3.0 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Neuromodulation Systems, Inc. (Ans Inc.). It received FDA 510(k) clearance on 2009-07-31 under 510(k) number K091993. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID PROGRAMMER, VERSION 3.3.0?

RAPID PROGRAMMER, VERSION 3.3.0 is a medical device that received FDA 510(k) clearance on 2009-07-31. The listed applicant is Advanced Neuromodulation Systems, Inc. (Ans Inc.). The 510(k) number is K091993.

When did RAPID PROGRAMMER, VERSION 3.3.0 receive FDA 510(k) clearance?

RAPID PROGRAMMER, VERSION 3.3.0 received FDA 510(k) clearance on 2009-07-31, under 510(k) number K091993.

Who is the listed applicant for RAPID PROGRAMMER, VERSION 3.3.0?

The FDA 510(k) record lists Advanced Neuromodulation Systems, Inc. (Ans Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID PROGRAMMER, VERSION 3.3.0?

The FDA product code for RAPID PROGRAMMER, VERSION 3.3.0 is GZB.

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Related Devices (Code: GZB)

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

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