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FDA 510(k)

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM

K-Number: K951605 · 1995-07-14

ApplicantSpacelabs, Inc.
Decision Date1995-07-14
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K951605. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM?

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Spacelabs, Inc.. The 510(k) number is K951605.

When did SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM receive FDA 510(k) clearance?

SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM received FDA 510(k) clearance on 1995-07-14, under 510(k) number K951605.

Who is the listed applicant for SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM?

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 MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM?

The FDA product code for SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEM is DSH.

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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 ANALYZERK950779HEART RATE VARIABILITY SOFTWARE OPTIONK941165COMET CAPNOGRAPH MODULEK923788SPACE LABS MODEL 90560K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBEK913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

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Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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