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FDA 510(k)

HOLTA-MED INFORMER PLAYBACK

K-Number: K832354 · 1984-01-27

ApplicantHolta-Med
Decision Date1984-01-27
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOLTA-MED INFORMER PLAYBACK is the device name listed in this FDA 510(k) record. The listed applicant is Holta-Med. It received FDA 510(k) clearance on 1984-01-27 under 510(k) number K832354. 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 HOLTA-MED INFORMER PLAYBACK?

HOLTA-MED INFORMER PLAYBACK is a medical device that received FDA 510(k) clearance on 1984-01-27. The listed applicant is Holta-Med. The 510(k) number is K832354.

When did HOLTA-MED INFORMER PLAYBACK receive FDA 510(k) clearance?

HOLTA-MED INFORMER PLAYBACK received FDA 510(k) clearance on 1984-01-27, under 510(k) number K832354.

Who is the listed applicant for HOLTA-MED INFORMER PLAYBACK?

The FDA 510(k) record lists Holta-Med as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLTA-MED INFORMER PLAYBACK?

The FDA product code for HOLTA-MED INFORMER PLAYBACK is DSI.

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Other records listing Holta-Med 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.

K832395HOLTA-MED RECORDER

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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