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FDA 510(k)

ANODYNE CC

K-Number: K963481 · 1997-08-11

ApplicantHeyer America, Inc.
Decision Date1997-08-11
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ANODYNE CC is the device name listed in this FDA 510(k) record. The listed applicant is Heyer America, Inc.. It received FDA 510(k) clearance on 1997-08-11 under 510(k) number K963481. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANODYNE CC?

ANODYNE CC is a medical device that received FDA 510(k) clearance on 1997-08-11. The listed applicant is Heyer America, Inc.. The 510(k) number is K963481.

When did ANODYNE CC receive FDA 510(k) clearance?

ANODYNE CC received FDA 510(k) clearance on 1997-08-11, under 510(k) number K963481.

Who is the listed applicant for ANODYNE CC?

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

What is the FDA product code for ANODYNE CC?

The FDA product code for ANODYNE CC is BSZ.

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 Heyer America, Inc. 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.

K001988MODULARK000995NARKOMAT, MODEL 2000K912566MINITROP AEROSOL UNIT

Related Devices (Code: BSZ)

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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