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FDA 510(k)

CARDIAC FIRST PASS ANALYSIS

K-Number: K921777 · 1992-08-12

ApplicantGE Medical Systems
Decision Date1992-08-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIAC FIRST PASS ANALYSIS 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 1992-08-12 under 510(k) number K921777. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC FIRST PASS ANALYSIS?

CARDIAC FIRST PASS ANALYSIS is a medical device that received FDA 510(k) clearance on 1992-08-12. The listed applicant is GE Medical Systems. The 510(k) number is K921777.

When did CARDIAC FIRST PASS ANALYSIS receive FDA 510(k) clearance?

CARDIAC FIRST PASS ANALYSIS received FDA 510(k) clearance on 1992-08-12, under 510(k) number K921777.

Who is the listed applicant for CARDIAC FIRST PASS ANALYSIS?

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 CARDIAC FIRST PASS ANALYSIS?

The FDA product code for CARDIAC FIRST PASS ANALYSIS is KPS.

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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: KPS)

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.

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.

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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