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FDA 510(k)

INTEGO

K-Number: K910904 · 1991-03-15

ApplicantRacal Health & Safety, Inc.
Decision Date1991-03-15
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTEGO is the device name listed in this FDA 510(k) record. The listed applicant is Racal Health & Safety, Inc.. It received FDA 510(k) clearance on 1991-03-15 under 510(k) number K910904. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGO?

INTEGO is a medical device that received FDA 510(k) clearance on 1991-03-15. The listed applicant is Racal Health & Safety, Inc.. The 510(k) number is K910904.

When did INTEGO receive FDA 510(k) clearance?

INTEGO received FDA 510(k) clearance on 1991-03-15, under 510(k) number K910904.

Who is the listed applicant for INTEGO?

The FDA 510(k) record lists Racal Health & Safety, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INTEGO?

The FDA product code for INTEGO is HQY.

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 Racal Health & Safety, 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.

K944397BNOS MICROVENT, MODEL AC AND MODEL AOK880534ZEPHYR

Related Devices (Code: HQY)

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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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