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FDA 510(k)

HEART RATE VARIABILITY SOFTWARE OPTION

K-Number: K950779 · 1995-04-25

ApplicantSpacelabs, Inc.
Decision Date1995-04-25
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEART RATE VARIABILITY SOFTWARE OPTION is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1995-04-25 under 510(k) number K950779. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEART RATE VARIABILITY SOFTWARE OPTION?

HEART RATE VARIABILITY SOFTWARE OPTION is a medical device that received FDA 510(k) clearance on 1995-04-25. The listed applicant is Spacelabs, Inc.. The 510(k) number is K950779.

When did HEART RATE VARIABILITY SOFTWARE OPTION receive FDA 510(k) clearance?

HEART RATE VARIABILITY SOFTWARE OPTION received FDA 510(k) clearance on 1995-04-25, under 510(k) number K950779.

Who is the listed applicant for HEART RATE VARIABILITY SOFTWARE OPTION?

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 HEART RATE VARIABILITY SOFTWARE OPTION?

The FDA product code for HEART RATE VARIABILITY SOFTWARE OPTION is DPS.

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Other records listing Spacelabs, 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.

K954962SPACELABS MEDICAL MULTIGAS ANALYZERK951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBEK913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

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Related Devices (Code: DPS)

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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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