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FDA 510(k)

PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III

K-Number: K860980 · 1986-05-21

ApplicantSpacelabs, Inc.
Decision Date1986-05-21
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1986-05-21 under 510(k) number K860980. 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 PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III?

PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III is a medical device that received FDA 510(k) clearance on 1986-05-21. The listed applicant is Spacelabs, Inc.. The 510(k) number is K860980.

When did PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III receive FDA 510(k) clearance?

PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III received FDA 510(k) clearance on 1986-05-21, under 510(k) number K860980.

Who is the listed applicant for PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III?

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

What is the FDA product code for PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III?

The FDA product code for PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III is DSI.

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Other records listing Spacelabs, Inc. as applicant

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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.

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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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