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FDA 510(k)

OR TUBE RESTRAINT

K-Number: K851874 · 1985-08-08

ApplicantKinetic Concepts, Inc.
Decision Date1985-08-08
Product CodeCBH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OR TUBE RESTRAINT is the device name listed in this FDA 510(k) record. The listed applicant is Kinetic Concepts, Inc.. It received FDA 510(k) clearance on 1985-08-08 under 510(k) number K851874. The device is classified under product code CBH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OR TUBE RESTRAINT?

OR TUBE RESTRAINT is a medical device that received FDA 510(k) clearance on 1985-08-08. The listed applicant is Kinetic Concepts, Inc.. The 510(k) number is K851874.

When did OR TUBE RESTRAINT receive FDA 510(k) clearance?

OR TUBE RESTRAINT received FDA 510(k) clearance on 1985-08-08, under 510(k) number K851874.

Who is the listed applicant for OR TUBE RESTRAINT?

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

What is the FDA product code for OR TUBE RESTRAINT?

The FDA product code for OR TUBE RESTRAINT is CBH.

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Other records listing Kinetic Concepts, Inc. as applicant

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Related Devices (Code: CBH)

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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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