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FDA 510(k)

KAWASUMI LABORATORIES K-CUFF

K-Number: K930012 · 1993-12-14

ApplicantKawasumi Laboratories Co., Ltd.
Decision Date1993-12-14
Product CodeKZD
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

KAWASUMI LABORATORIES K-CUFF is the device name listed in this FDA 510(k) record. The listed applicant is Kawasumi Laboratories Co., Ltd.. It received FDA 510(k) clearance on 1993-12-14 under 510(k) number K930012. The device is classified under product code KZD. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAWASUMI LABORATORIES K-CUFF?

KAWASUMI LABORATORIES K-CUFF is a medical device that received FDA 510(k) clearance on 1993-12-14. The listed applicant is Kawasumi Laboratories Co., Ltd.. The 510(k) number is K930012.

When did KAWASUMI LABORATORIES K-CUFF receive FDA 510(k) clearance?

KAWASUMI LABORATORIES K-CUFF received FDA 510(k) clearance on 1993-12-14, under 510(k) number K930012.

Who is the listed applicant for KAWASUMI LABORATORIES K-CUFF?

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

What is the FDA product code for KAWASUMI LABORATORIES K-CUFF?

The FDA product code for KAWASUMI LABORATORIES K-CUFF is KZD.

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Other records listing Kawasumi Laboratories Co., Ltd. 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.

K994323KAWASUMI LABORATORIES PHILEBOTOMY SETK974829NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)K964117NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITEK935514VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDERK935505WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTERK935506MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION

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Related Devices (Code: KZD)

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.

K974074INFUSION DYNAMICS POWER INFUSERInfusion Dynamics, Inc.K973843MSI PRESSURE INFUSORSmith Assoc.K953290OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMPOlympus America, Inc.K951988PRESSURIZERPromedic, Inc.K942933PRESSURE INFUSION CUFFCirculatory Technology, Inc.K921168ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000Allen Medical Systems, 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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