Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPEACELABS MULTIGAS MODULE

K-Number: K112173 · 2011-10-05

ApplicantSpacelabs Healthcare
Decision Date2011-10-05
Product CodeCBR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SPEACELABS MULTIGAS MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Spacelabs Healthcare. It received FDA 510(k) clearance on 2011-10-05 under 510(k) number K112173. The device is classified under product code CBR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPEACELABS MULTIGAS MODULE?

SPEACELABS MULTIGAS MODULE is a medical device that received FDA 510(k) clearance on 2011-10-05. The listed applicant is Spacelabs Healthcare. The 510(k) number is K112173.

When did SPEACELABS MULTIGAS MODULE receive FDA 510(k) clearance?

SPEACELABS MULTIGAS MODULE received FDA 510(k) clearance on 2011-10-05, under 510(k) number K112173.

Who is the listed applicant for SPEACELABS MULTIGAS MODULE?

The FDA 510(k) record lists Spacelabs Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPEACELABS MULTIGAS MODULE?

The FDA product code for SPEACELABS MULTIGAS MODULE is CBR.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Spacelabs Healthcare 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.

K122146XHIBIT CENTRAL STATION, MODEL 96102K130112CAPNO MODULE, 92517K121017CAPNOGRAPHY PAD (92516)K112729BLEASE700/900 SERIES VENTILATORSK121480ARIATELE TELEMETRY TRANSMITTER (96281)K113051SPACELABS ARKON ANESTHESIA WORKSTATION

View all 8 devices →

Related Devices (Code: CBR)

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.

K053599SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIESSpacelabs Medical, Inc.K954962SPACELABS MEDICAL MULTIGAS ANALYZERSpacelabs, Inc.K904843OSCAR(TM) II CAPNOMETER & PULSE OXIMETERDalton Instrument Corp.K853360N20 TESTErich Jaeger, 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.

↑