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FDA 510(k)

SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION

K-Number: K913038 · 1991-10-04

ApplicantSpacelabs, Inc.
Decision Date1991-10-04
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1991-10-04 under 510(k) number K913038. 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 SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION?

SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION is a medical device that received FDA 510(k) clearance on 1991-10-04. The listed applicant is Spacelabs, Inc.. The 510(k) number is K913038.

When did SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION receive FDA 510(k) clearance?

SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION received FDA 510(k) clearance on 1991-10-04, under 510(k) number K913038.

Who is the listed applicant for SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION?

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 SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION?

The FDA product code for SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATION 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 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: 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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