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FDA 510(k)

EXALT Model B Single-Use Bronchoscope

K-Number: K222014 · 2022-07-28

ApplicantBoston Scientific Corporation
Decision Date2022-07-28
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

EXALT Model B Single-Use Bronchoscope is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-07-28 under approval number K222014. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXALT Model B Single-Use Bronchoscope?

EXALT Model B Single-Use Bronchoscope is a medical device that received FDA 510(k) clearance on 2022-07-28. It is manufactured by Boston Scientific Corporation. The 510(k) number is K222014.

When was EXALT Model B Single-Use Bronchoscope approved by the FDA?

EXALT Model B Single-Use Bronchoscope received FDA 510(k) clearance on 2022-07-28, under approval number K222014.

What company makes EXALT Model B Single-Use Bronchoscope?

EXALT Model B Single-Use Bronchoscope is manufactured by Boston Scientific Corporation.

What is the FDA product code for EXALT Model B Single-Use Bronchoscope?

The FDA product code for EXALT Model B Single-Use Bronchoscope is EOQ.

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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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