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FDA 510(k)

PNEUMOTHERML, MODEL: 5800

K-Number: K092685 · 2009-11-24

ApplicantSalter Labs
Decision Date2009-11-24
Product CodeBZQ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PNEUMOTHERML, MODEL: 5800 is the device name listed in this FDA 510(k) record. The listed applicant is Salter Labs. It received FDA 510(k) clearance on 2009-11-24 under 510(k) number K092685. The device is classified under product code BZQ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PNEUMOTHERML, MODEL: 5800?

PNEUMOTHERML, MODEL: 5800 is a medical device that received FDA 510(k) clearance on 2009-11-24. The listed applicant is Salter Labs. The 510(k) number is K092685.

When did PNEUMOTHERML, MODEL: 5800 receive FDA 510(k) clearance?

PNEUMOTHERML, MODEL: 5800 received FDA 510(k) clearance on 2009-11-24, under 510(k) number K092685.

Who is the listed applicant for PNEUMOTHERML, MODEL: 5800?

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

What is the FDA product code for PNEUMOTHERML, MODEL: 5800?

The FDA product code for PNEUMOTHERML, MODEL: 5800 is BZQ.

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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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