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FDA 510(k)

DISPOSABLE COLOR-CUFFS

K-Number: K890014 · 1989-01-24

ApplicantInstrumed, Inc.
Decision Date1989-01-24
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE COLOR-CUFFS is the device name listed in this FDA 510(k) record. The listed applicant is Instrumed, Inc.. It received FDA 510(k) clearance on 1989-01-24 under 510(k) number K890014. The device is classified under product code KCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE COLOR-CUFFS?

DISPOSABLE COLOR-CUFFS is a medical device that received FDA 510(k) clearance on 1989-01-24. The listed applicant is Instrumed, Inc.. The 510(k) number is K890014.

When did DISPOSABLE COLOR-CUFFS receive FDA 510(k) clearance?

DISPOSABLE COLOR-CUFFS received FDA 510(k) clearance on 1989-01-24, under 510(k) number K890014.

Who is the listed applicant for DISPOSABLE COLOR-CUFFS?

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

What is the FDA product code for DISPOSABLE COLOR-CUFFS?

The FDA product code for DISPOSABLE COLOR-CUFFS is KCY.

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Other records listing Instrumed, 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.

K952038CLEAN-CUFFK940615ACCUTESTK924273ACCUFLATEK924373ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMPK910512ACCUFLATEK860617POLYPET

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Related Devices (Code: KCY)

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.

K202919ATS 5000 Automatic Tourniquet InstrumentMcewen and Associates Consulting , Ltd.K162365T-CuffTerumobct, Inc.K123553ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.K112874EZ VEIN INFLATABLE TOURNIQUETDominion Medical Devices, LLCK071140MRI COMPATIBLE THIGH TOURNIQUET, MODEL C070002Top Spins, Inc.K050411ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEMZimmer, Inc.

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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