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)

BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE

K-Number: K921388 · 1993-05-26

ApplicantBiochem International, Inc.
Decision Date1993-05-26
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Biochem International, Inc.. It received FDA 510(k) clearance on 1993-05-26 under 510(k) number K921388. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE?

BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE is a medical device that received FDA 510(k) clearance on 1993-05-26. The listed applicant is Biochem International, Inc.. The 510(k) number is K921388.

When did BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE receive FDA 510(k) clearance?

BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE received FDA 510(k) clearance on 1993-05-26, under 510(k) number K921388.

Who is the listed applicant for BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE?

The FDA 510(k) record lists Biochem International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE?

The FDA product code for BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE is DSK.

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 Biochem International, 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.

K920083BIOCHEM MODEL 3302 NEWOX2 OXIMETERK9323898100 ANESTHETIC AGENT MONITORK920082BIOCHEM MODEL 3301 NEWOX1 OXIMETERK911351BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBPK910381BIOCHEM TEMPERATURE/ FIO2 MODULEK903222BIOCHEM 6100 NON-INVASIVE MONITOR

View all 28 devices →

Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, 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.

↑