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FDA 510(k)

3 IN 1 AUTOMATIC TOURNIQUET

K-Number: K880020 · 1988-03-17

ApplicantSystematics Mfg. & Tool Co., Inc.
Decision Date1988-03-17
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3 IN 1 AUTOMATIC TOURNIQUET is the device name listed in this FDA 510(k) record. The listed applicant is Systematics Mfg. & Tool Co., Inc.. It received FDA 510(k) clearance on 1988-03-17 under 510(k) number K880020. 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 3 IN 1 AUTOMATIC TOURNIQUET?

3 IN 1 AUTOMATIC TOURNIQUET is a medical device that received FDA 510(k) clearance on 1988-03-17. The listed applicant is Systematics Mfg. & Tool Co., Inc.. The 510(k) number is K880020.

When did 3 IN 1 AUTOMATIC TOURNIQUET receive FDA 510(k) clearance?

3 IN 1 AUTOMATIC TOURNIQUET received FDA 510(k) clearance on 1988-03-17, under 510(k) number K880020.

Who is the listed applicant for 3 IN 1 AUTOMATIC TOURNIQUET?

The FDA 510(k) record lists Systematics Mfg. & Tool Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 IN 1 AUTOMATIC TOURNIQUET?

The FDA product code for 3 IN 1 AUTOMATIC TOURNIQUET is KCY.

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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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