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FDA 510(k)

STEALTH

K-Number: K972036 · 1997-07-03

ApplicantThe Buzzz Corp.
Decision Date1997-07-03
Product CodeINI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

STEALTH is the device name listed in this FDA 510(k) record. The listed applicant is The Buzzz Corp.. It received FDA 510(k) clearance on 1997-07-03 under 510(k) number K972036. The device is classified under product code INI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEALTH?

STEALTH is a medical device that received FDA 510(k) clearance on 1997-07-03. The listed applicant is The Buzzz Corp.. The 510(k) number is K972036.

When did STEALTH receive FDA 510(k) clearance?

STEALTH received FDA 510(k) clearance on 1997-07-03, under 510(k) number K972036.

Who is the listed applicant for STEALTH?

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

What is the FDA product code for STEALTH?

The FDA product code for STEALTH is INI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing The Buzzz Corp. 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.

K973373PREVENT IK972037PROWLERK972038INTRUDER

Related Devices (Code: INI)

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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