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FDA 510(k)

TOURNI-COMP

K-Number: K954103 · 1995-11-01

ApplicantScandinavian Medical JW AB
Decision Date1995-11-01
Product CodeKCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TOURNI-COMP is the device name listed in this FDA 510(k) record. The listed applicant is Scandinavian Medical JW AB. It received FDA 510(k) clearance on 1995-11-01 under 510(k) number K954103. 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 TOURNI-COMP?

TOURNI-COMP is a medical device that received FDA 510(k) clearance on 1995-11-01. The listed applicant is Scandinavian Medical JW AB. The 510(k) number is K954103.

When did TOURNI-COMP receive FDA 510(k) clearance?

TOURNI-COMP received FDA 510(k) clearance on 1995-11-01, under 510(k) number K954103.

Who is the listed applicant for TOURNI-COMP?

The FDA 510(k) record lists Scandinavian Medical JW AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOURNI-COMP?

The FDA product code for TOURNI-COMP 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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