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FDA 510(k)

COMBISON COMPUTER

K-Number: K800092 · 1980-04-08

ApplicantKt Medical, Inc.
Decision Date1980-04-08
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMBISON COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Kt Medical, Inc.. It received FDA 510(k) clearance on 1980-04-08 under 510(k) number K800092. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBISON COMPUTER?

COMBISON COMPUTER is a medical device that received FDA 510(k) clearance on 1980-04-08. The listed applicant is Kt Medical, Inc.. The 510(k) number is K800092.

When did COMBISON COMPUTER receive FDA 510(k) clearance?

COMBISON COMPUTER received FDA 510(k) clearance on 1980-04-08, under 510(k) number K800092.

Who is the listed applicant for COMBISON COMPUTER?

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

What is the FDA product code for COMBISON COMPUTER?

The FDA product code for COMBISON COMPUTER is DQK.

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Other records listing Kt Medical, Inc. 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.

K800653SINVISION LINEAR ARRAY REAL TIMEK800652MODEL E03 ECHO-OPTHALMOSCOPEK8001014200 ME ECHOENCEPHALOGRAPHK800099INTRACULA IIK8001007200 MA ECHO-OPHTHALMOSCOPEK800093TRANSDUCER

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Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, 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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