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FDA 510(k)

MULTISPIRO-BREEZE

K-Number: K913681 · 1992-07-02

ApplicantMultispiro, Inc.
Decision Date1992-07-02
Product CodeBZC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MULTISPIRO-BREEZE is the device name listed in this FDA 510(k) record. The listed applicant is Multispiro, Inc.. It received FDA 510(k) clearance on 1992-07-02 under 510(k) number K913681. The device is classified under product code BZC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTISPIRO-BREEZE?

MULTISPIRO-BREEZE is a medical device that received FDA 510(k) clearance on 1992-07-02. The listed applicant is Multispiro, Inc.. The 510(k) number is K913681.

When did MULTISPIRO-BREEZE receive FDA 510(k) clearance?

MULTISPIRO-BREEZE received FDA 510(k) clearance on 1992-07-02, under 510(k) number K913681.

Who is the listed applicant for MULTISPIRO-BREEZE?

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

What is the FDA product code for MULTISPIRO-BREEZE?

The FDA product code for MULTISPIRO-BREEZE is BZC.

Related Clinical Trials

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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Other records listing Multispiro, Inc. as applicant

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.

K920390THE PEAKK915451MULTISPIRO-SX

Related Devices (Code: BZC)

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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