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FDA 510(k)

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE

K-Number: K860689 · 1986-07-30

ApplicantSpacelabs, Inc.
Decision Date1986-07-30
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1986-07-30 under 510(k) number K860689. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE?

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE is a medical device that received FDA 510(k) clearance on 1986-07-30. The listed applicant is Spacelabs, Inc.. The 510(k) number is K860689.

When did SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE receive FDA 510(k) clearance?

SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE received FDA 510(k) clearance on 1986-07-30, under 510(k) number K860689.

Who is the listed applicant for SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE?

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 SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE?

The FDA product code for SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE is DSK.

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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 SYSTEMK950779HEART RATE VARIABILITY SOFTWARE OPTIONK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

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Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, Inc.

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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