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FDA 510(k)

FETALGARD LITE-NIBP, MODEL FGL-NIBP

K-Number: K051903 · 2005-12-27

ApplicantAnalogic Corporation
Decision Date2005-12-27
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FETALGARD LITE-NIBP, MODEL FGL-NIBP is the device name listed in this FDA 510(k) record. The listed applicant is Analogic Corporation. It received FDA 510(k) clearance on 2005-12-27 under 510(k) number K051903. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETALGARD LITE-NIBP, MODEL FGL-NIBP?

FETALGARD LITE-NIBP, MODEL FGL-NIBP is a medical device that received FDA 510(k) clearance on 2005-12-27. The listed applicant is Analogic Corporation. The 510(k) number is K051903.

When did FETALGARD LITE-NIBP, MODEL FGL-NIBP receive FDA 510(k) clearance?

FETALGARD LITE-NIBP, MODEL FGL-NIBP received FDA 510(k) clearance on 2005-12-27, under 510(k) number K051903.

Who is the listed applicant for FETALGARD LITE-NIBP, MODEL FGL-NIBP?

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

What is the FDA product code for FETALGARD LITE-NIBP, MODEL FGL-NIBP?

The FDA product code for FETALGARD LITE-NIBP, MODEL FGL-NIBP is DXN.

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Other records listing Analogic Corporation 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.

K201231CTxx85 CT ScannerK182147CTXX85K172058CT6485, CT12885K161342Sonic WindowK070829SYNEPIX 4600 DETECTOR

Related Devices (Code: DXN)

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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