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FDA 510(k)

SMART BREATH RESPIRATORY COMPENSATION OPTION

K-Number: K022919 · 2002-09-19

ApplicantGE Medical Systems
Decision Date2002-09-19
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMART BREATH RESPIRATORY COMPENSATION OPTION is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 2002-09-19 under 510(k) number K022919. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMART BREATH RESPIRATORY COMPENSATION OPTION?

SMART BREATH RESPIRATORY COMPENSATION OPTION is a medical device that received FDA 510(k) clearance on 2002-09-19. The listed applicant is GE Medical Systems. The 510(k) number is K022919.

When did SMART BREATH RESPIRATORY COMPENSATION OPTION receive FDA 510(k) clearance?

SMART BREATH RESPIRATORY COMPENSATION OPTION received FDA 510(k) clearance on 2002-09-19, under 510(k) number K022919.

Who is the listed applicant for SMART BREATH RESPIRATORY COMPENSATION OPTION?

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

What is the FDA product code for SMART BREATH RESPIRATORY COMPENSATION OPTION?

The FDA product code for SMART BREATH RESPIRATORY COMPENSATION OPTION is JAK.

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Other records listing GE Medical Systems 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.

K253808AIR Recon DLK220848Venue FitK220851VenueK173341Vivid E80, Vivid E90, Vivid E95K103411IDEAL IQ SOFTWARE OPTIONK073138CARDIQ EXPRESS VERSION 2.0

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Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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