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FDA 510(k)

BRONCHOSCOPY ELBOW

K-Number: K132168 · 2013-11-20

ApplicantRespironics, Inc.
Decision Date2013-11-20
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BRONCHOSCOPY ELBOW is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2013-11-20 under 510(k) number K132168. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRONCHOSCOPY ELBOW?

BRONCHOSCOPY ELBOW is a medical device that received FDA 510(k) clearance on 2013-11-20. The listed applicant is Respironics, Inc.. The 510(k) number is K132168.

When did BRONCHOSCOPY ELBOW receive FDA 510(k) clearance?

BRONCHOSCOPY ELBOW received FDA 510(k) clearance on 2013-11-20, under 510(k) number K132168.

Who is the listed applicant for BRONCHOSCOPY ELBOW?

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

What is the FDA product code for BRONCHOSCOPY ELBOW?

The FDA product code for BRONCHOSCOPY ELBOW is BZD.

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Related Devices (Code: BZD)

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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