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FDA 510(k)

OFF-LINE ANALYSIS SYSTEM

K-Number: K921216 · 1992-11-20

ApplicantSoftheart, Inc.
Decision Date1992-11-20
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OFF-LINE ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Softheart, Inc.. It received FDA 510(k) clearance on 1992-11-20 under 510(k) number K921216. 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 OFF-LINE ANALYSIS SYSTEM?

OFF-LINE ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 1992-11-20. The listed applicant is Softheart, Inc.. The 510(k) number is K921216.

When did OFF-LINE ANALYSIS SYSTEM receive FDA 510(k) clearance?

OFF-LINE ANALYSIS SYSTEM received FDA 510(k) clearance on 1992-11-20, under 510(k) number K921216.

Who is the listed applicant for OFF-LINE ANALYSIS SYSTEM?

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

What is the FDA product code for OFF-LINE ANALYSIS SYSTEM?

The FDA product code for OFF-LINE ANALYSIS SYSTEM is DQK.

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 Softheart, 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.

K930639ON-LINE ANALYSIS SYSTEMK914105CATHWRITER(TM)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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