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FDA 510(k)

SPACELABS SERIES 600 PATIENT MONITORS

K-Number: K844888 · 1985-02-01

ApplicantSpacelabs, Inc.
Decision Date1985-02-01
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS SERIES 600 PATIENT MONITORS is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1985-02-01 under 510(k) number K844888. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS SERIES 600 PATIENT MONITORS?

SPACELABS SERIES 600 PATIENT MONITORS is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Spacelabs, Inc.. The 510(k) number is K844888.

When did SPACELABS SERIES 600 PATIENT MONITORS receive FDA 510(k) clearance?

SPACELABS SERIES 600 PATIENT MONITORS received FDA 510(k) clearance on 1985-02-01, under 510(k) number K844888.

Who is the listed applicant for SPACELABS SERIES 600 PATIENT MONITORS?

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 SERIES 600 PATIENT MONITORS?

The FDA product code for SPACELABS SERIES 600 PATIENT MONITORS is DRT.

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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: DRT)

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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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