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FDA 510(k)

Rapid HB, Rapid LB, Rapid MB

K-Number: K173318 · 2017-10-31

Applicant3M Deutschland GmbH
Decision Date2017-10-31
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Rapid HB, Rapid LB, Rapid MB is the device name listed in this FDA 510(k) record. The listed applicant is 3M Deutschland GmbH. It received FDA 510(k) clearance on 2017-10-31 under 510(k) number K173318. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Rapid HB, Rapid LB, Rapid MB?

Rapid HB, Rapid LB, Rapid MB is a medical device that received FDA 510(k) clearance on 2017-10-31. The listed applicant is 3M Deutschland GmbH. The 510(k) number is K173318.

When did Rapid HB, Rapid LB, Rapid MB receive FDA 510(k) clearance?

Rapid HB, Rapid LB, Rapid MB received FDA 510(k) clearance on 2017-10-31, under 510(k) number K173318.

Who is the listed applicant for Rapid HB, Rapid LB, Rapid MB?

The FDA 510(k) record lists 3M Deutschland GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rapid HB, Rapid LB, Rapid MB?

The FDA product code for Rapid HB, Rapid LB, Rapid MB is ELW.

Other records listing 3M Deutschland GmbH as applicant

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Related Devices (Code: ELW)

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.

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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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