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FDA 510(k)

SCOPE INTRODUCER MODEL 7400

K-Number: K093329 · 2010-02-16

ApplicantN.M. Beale Co., Inc.
Decision Date2010-02-16
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SCOPE INTRODUCER MODEL 7400 is the device name listed in this FDA 510(k) record. The listed applicant is N.M. Beale Co., Inc.. It received FDA 510(k) clearance on 2010-02-16 under 510(k) number K093329. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOPE INTRODUCER MODEL 7400?

SCOPE INTRODUCER MODEL 7400 is a medical device that received FDA 510(k) clearance on 2010-02-16. The listed applicant is N.M. Beale Co., Inc.. The 510(k) number is K093329.

When did SCOPE INTRODUCER MODEL 7400 receive FDA 510(k) clearance?

SCOPE INTRODUCER MODEL 7400 received FDA 510(k) clearance on 2010-02-16, under 510(k) number K093329.

Who is the listed applicant for SCOPE INTRODUCER MODEL 7400?

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

What is the FDA product code for SCOPE INTRODUCER MODEL 7400?

The FDA product code for SCOPE INTRODUCER MODEL 7400 is ODC.

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Other records listing N.M. Beale Co., 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.

K093584EZ-MISTERK071579PEF TUBEK992178BALLOON FOR ULTRASONIC ENDOSCOPESK903834N. M. BEALE COMPANY VU-THRU WATER BOTTLE

Related Devices (Code: ODC)

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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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