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FDA 510(k)

GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE

K-Number: K041149 · 2004-10-25

ApplicantGiven Imaging , Ltd.
Decision Date2004-10-25
Product CodeNSI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging , Ltd.. It received FDA 510(k) clearance on 2004-10-25 under 510(k) number K041149. The device is classified under product code NSI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE?

GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE is a medical device that received FDA 510(k) clearance on 2004-10-25. The listed applicant is Given Imaging , Ltd.. The 510(k) number is K041149.

When did GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE receive FDA 510(k) clearance?

GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE received FDA 510(k) clearance on 2004-10-25, under 510(k) number K041149.

Who is the listed applicant for GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE?

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

What is the FDA product code for GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE?

The FDA product code for GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE is NSI.

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Other records listing Given Imaging , Ltd. as applicant

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Related Devices (Code: NSI)

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.

K180171PillCam Patency SystemGiven Imaging , Ltd.K090557GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEMGiven Imaging , Ltd.K071153GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO2 CAPSULEGiven Imaging , Ltd.K060805MODIFICATION TO GIVEN DIAGNOSTIC SYSTEMGiven Imaging , Ltd.K052184GIVEN DIAGNOSTIC SYSTEMGiven Imaging , Ltd.K042960GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESOGiven Imaging , Ltd.

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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