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FDA 510(k)

COMPU-SCAN

K-Number: K791632 · 1979-11-13

ApplicantHittman Medical Systems
Decision Date1979-11-13
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPU-SCAN is the device name listed in this FDA 510(k) record. The listed applicant is Hittman Medical Systems. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K791632. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPU-SCAN?

COMPU-SCAN is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Hittman Medical Systems. The 510(k) number is K791632.

When did COMPU-SCAN receive FDA 510(k) clearance?

COMPU-SCAN received FDA 510(k) clearance on 1979-11-13, under 510(k) number K791632.

Who is the listed applicant for COMPU-SCAN?

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

What is the FDA product code for COMPU-SCAN?

The FDA product code for COMPU-SCAN is DSI.

Related Clinical Trials

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.

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Other records listing Hittman 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.

K832772SATURN-24HR. HOLTER SCANNERK790300META III

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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