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FDA 510(k)

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE

K-Number: K101889 · 2010-08-27

ApplicantPivotal Health Solutions
Decision Date2010-08-27
Product CodeITH
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Pivotal Health Solutions. It received FDA 510(k) clearance on 2010-08-27 under 510(k) number K101889. The device is classified under product code ITH. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE?

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE is a medical device that received FDA 510(k) clearance on 2010-08-27. The listed applicant is Pivotal Health Solutions. The 510(k) number is K101889.

When did DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE receive FDA 510(k) clearance?

DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE received FDA 510(k) clearance on 2010-08-27, under 510(k) number K101889.

Who is the listed applicant for DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE?

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

What is the FDA product code for DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE?

The FDA product code for DECOMPRESSION OF CHOICE AND NEURO DECOMPRESSION DEVICE is ITH.

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Related Devices (Code: ITH)

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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