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FDA 510(k)

ESPIRT

K-Number: K001208 · 2000-05-12

ApplicantRespironics, Inc.
Decision Date2000-05-12
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESPIRT is the device name listed in this FDA 510(k) record. The listed applicant is Respironics, Inc.. It received FDA 510(k) clearance on 2000-05-12 under 510(k) number K001208. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESPIRT?

ESPIRT is a medical device that received FDA 510(k) clearance on 2000-05-12. The listed applicant is Respironics, Inc.. The 510(k) number is K001208.

When did ESPIRT receive FDA 510(k) clearance?

ESPIRT received FDA 510(k) clearance on 2000-05-12, under 510(k) number K001208.

Who is the listed applicant for ESPIRT?

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 ESPIRT?

The FDA product code for ESPIRT is CBK.

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Related Devices (Code: CBK)

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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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