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FDA 510(k)

MARCELLA CARAN

K-Number: K962912 · 1996-08-22

ApplicantFramesmart, Inc.
Decision Date1996-08-22
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MARCELLA CARAN is the device name listed in this FDA 510(k) record. The listed applicant is Framesmart, Inc.. It received FDA 510(k) clearance on 1996-08-22 under 510(k) number K962912. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARCELLA CARAN?

MARCELLA CARAN is a medical device that received FDA 510(k) clearance on 1996-08-22. The listed applicant is Framesmart, Inc.. The 510(k) number is K962912.

When did MARCELLA CARAN receive FDA 510(k) clearance?

MARCELLA CARAN received FDA 510(k) clearance on 1996-08-22, under 510(k) number K962912.

Who is the listed applicant for MARCELLA CARAN?

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

What is the FDA product code for MARCELLA CARAN?

The FDA product code for MARCELLA CARAN is HQY.

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 Framesmart, 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.

K963075FITO DIDO

Related Devices (Code: HQY)

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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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