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FDA 510(k)

NOVA 12 CARDIAC OUTPUT COMPUTER

K-Number: K840009 · 1984-08-22

ApplicantNova Medical Specialties
Decision Date1984-08-22
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NOVA 12 CARDIAC OUTPUT COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Nova Medical Specialties. It received FDA 510(k) clearance on 1984-08-22 under 510(k) number K840009. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NOVA 12 CARDIAC OUTPUT COMPUTER?

NOVA 12 CARDIAC OUTPUT COMPUTER is a medical device that received FDA 510(k) clearance on 1984-08-22. The listed applicant is Nova Medical Specialties. The 510(k) number is K840009.

When did NOVA 12 CARDIAC OUTPUT COMPUTER receive FDA 510(k) clearance?

NOVA 12 CARDIAC OUTPUT COMPUTER received FDA 510(k) clearance on 1984-08-22, under 510(k) number K840009.

Who is the listed applicant for NOVA 12 CARDIAC OUTPUT COMPUTER?

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

What is the FDA product code for NOVA 12 CARDIAC OUTPUT COMPUTER?

The FDA product code for NOVA 12 CARDIAC OUTPUT COMPUTER is DXG.

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Other records listing Nova Medical Specialties 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.

K872770DUAL-THERMISTOR THERMODILUTION CATH. & INFU. CATH.K860526NOVA BALLOON THERMODILUTION PRESSURE TRANS CATHK853625NOVA ARTERIAL EMBOLECTOMY CATHETERK841640NOVA BALLOON THERMODILUTION INFUSIONK841639NOVA BALLOON THERMODILUTION CATH.K834037HEPARIN COATED BALLOON THERMODILU

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Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, 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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