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FDA 510(k)

SMARTSCOPE

K-Number: K932533 · 1994-03-31

ApplicantInsight Medical Corp.
Decision Date1994-03-31
Product CodeJXE
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SMARTSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Insight Medical Corp.. It received FDA 510(k) clearance on 1994-03-31 under 510(k) number K932533. The device is classified under product code JXE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTSCOPE?

SMARTSCOPE is a medical device that received FDA 510(k) clearance on 1994-03-31. The listed applicant is Insight Medical Corp.. The 510(k) number is K932533.

When did SMARTSCOPE receive FDA 510(k) clearance?

SMARTSCOPE received FDA 510(k) clearance on 1994-03-31, under 510(k) number K932533.

Who is the listed applicant for SMARTSCOPE?

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

What is the FDA product code for SMARTSCOPE?

The FDA product code for SMARTSCOPE is JXE.

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 Insight Medical 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.

K974645FEMASSIST FLEXIBLEK963858FEMASSIST URINARY DEVICE

Related Devices (Code: JXE)

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.

K240189NM-01/CPT neurometer (NM-01/CPT)Mde Orvosbiológiai Kutató, Fejleszto,K190536Mediracer NCSMediracer OYK070109NEUROMETRIX ADVANCENeurometrix, Inc.K060584NC-STATNeurometrix, Inc.K053058XLTEK NEUROPATH, MODEL PK1070Excel Tech. , Ltd.K052904VIRTUAL MEDICAL SYSTEMS MODEL VT3000Scientific Imaging, Inc.

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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