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FDA 510(k)

SPACELABS-GENERAL SYSTEM LINK

K-Number: K850627 · 1985-05-28

ApplicantSpacelabs, Inc.
Decision Date1985-05-28
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SPACELABS-GENERAL SYSTEM LINK is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs, Inc.. It received FDA 510(k) clearance on 1985-05-28 under 510(k) number K850627. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPACELABS-GENERAL SYSTEM LINK?

SPACELABS-GENERAL SYSTEM LINK is a medical device that received FDA 510(k) clearance on 1985-05-28. The listed applicant is Spacelabs, Inc.. The 510(k) number is K850627.

When did SPACELABS-GENERAL SYSTEM LINK receive FDA 510(k) clearance?

SPACELABS-GENERAL SYSTEM LINK received FDA 510(k) clearance on 1985-05-28, under 510(k) number K850627.

Who is the listed applicant for SPACELABS-GENERAL SYSTEM LINK?

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-GENERAL SYSTEM LINK?

The FDA product code for SPACELABS-GENERAL SYSTEM LINK is DQK.

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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: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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