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FDA 510(k)

VIEWPOINT

K-Number: K961168 · 1996-05-16

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1996-05-16
Product CodeGAW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VIEWPOINT is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1996-05-16 under 510(k) number K961168. The device is classified under product code GAW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIEWPOINT?

VIEWPOINT is a medical device that received FDA 510(k) clearance on 1996-05-16. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K961168.

When did VIEWPOINT receive FDA 510(k) clearance?

VIEWPOINT received FDA 510(k) clearance on 1996-05-16, under 510(k) number K961168.

Who is the listed applicant for VIEWPOINT?

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

What is the FDA product code for VIEWPOINT?

The FDA product code for VIEWPOINT is GAW.

Related Clinical Trials

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Related PubMed Literature

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.

PMID: 37579360Impact of the Regulatory Framework on Medical Device Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation? Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It? - A Viewpoint Paper".International journal of health policy and management ()

Other records listing Philips Medical Systems (Cleveland), Inc. as applicant

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Related Devices (Code: GAW)

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K253572STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control DeviceETHICON, Inc.K233355Cypris eXact Suturing SystemCypris MedicalK230746Non absorbable Surgical Polypropylene SutureShandong Haidike Medical Products Co., Ltd.K221280VessealLydus Medical , Ltd.K211178DURAMESH Mesh SutureMsiK192953APTOS Threads – Polypropylene Surgical SuturesAptos, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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