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FDA 510(k)

STATVIEW

K-Number: K913755 · 1991-11-19

ApplicantImage Systems, Inc.
Decision Date1991-11-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

STATVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Image Systems, Inc.. It received FDA 510(k) clearance on 1991-11-19 under 510(k) number K913755. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STATVIEW?

STATVIEW is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Image Systems, Inc.. The 510(k) number is K913755.

When did STATVIEW receive FDA 510(k) clearance?

STATVIEW received FDA 510(k) clearance on 1991-11-19, under 510(k) number K913755.

Who is the listed applicant for STATVIEW?

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

What is the FDA product code for STATVIEW?

The FDA product code for STATVIEW is LLZ.

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 Image Systems, 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.

K901422SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOFK844771INFRAVIEW/INFRASION-TELETHERMOGRAPHIC SYSTEM

Related Devices (Code: LLZ)

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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