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FDA 510(k)

DIASCOPE TRAVELLER PLUS (4053)

K-Number: K964593 · 1997-06-30

ApplicantS & W Medico Teknik A/S
Decision Date1997-06-30
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DIASCOPE TRAVELLER PLUS (4053) is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik A/S. It received FDA 510(k) clearance on 1997-06-30 under 510(k) number K964593. 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 DIASCOPE TRAVELLER PLUS (4053)?

DIASCOPE TRAVELLER PLUS (4053) is a medical device that received FDA 510(k) clearance on 1997-06-30. The listed applicant is S & W Medico Teknik A/S. The 510(k) number is K964593.

When did DIASCOPE TRAVELLER PLUS (4053) receive FDA 510(k) clearance?

DIASCOPE TRAVELLER PLUS (4053) received FDA 510(k) clearance on 1997-06-30, under 510(k) number K964593.

Who is the listed applicant for DIASCOPE TRAVELLER PLUS (4053)?

The FDA 510(k) record lists S & W Medico Teknik A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIASCOPE TRAVELLER PLUS (4053)?

The FDA product code for DIASCOPE TRAVELLER PLUS (4053) is DSI.

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Other records listing S & W Medico Teknik A/S 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.

K9421963050 DIASCOPE NT PATIENT MONITORK9348879750 ATHENA ETHERNET OPTION

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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