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FDA 510(k)

SPECTRAPULSE

K-Number: K022607 · 2002-12-20

ApplicantPrimary Technology, LLC
Decision Date2002-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SPECTRAPULSE is the device name listed in this FDA 510(k) record. The listed applicant is Primary Technology, LLC. It received FDA 510(k) clearance on 2002-12-20 under 510(k) number K022607. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRAPULSE?

SPECTRAPULSE is a medical device that received FDA 510(k) clearance on 2002-12-20. The listed applicant is Primary Technology, LLC. The 510(k) number is K022607.

When did SPECTRAPULSE receive FDA 510(k) clearance?

SPECTRAPULSE received FDA 510(k) clearance on 2002-12-20, under 510(k) number K022607.

Who is the listed applicant for SPECTRAPULSE?

The FDA 510(k) record lists Primary Technology, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRAPULSE?

The FDA product code for SPECTRAPULSE is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Primary Technology, LLC 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.

K031680SPECTRAPULSE

Related Devices (Code: GEX)

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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