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)

CONTROLLED TEMPERATURE CABINET SYSTEM

K-Number: K973747 · 1998-05-07

ApplicantSmith
Decision Date1998-05-07
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CONTROLLED TEMPERATURE CABINET SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith. It received FDA 510(k) clearance on 1998-05-07 under 510(k) number K973747. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROLLED TEMPERATURE CABINET SYSTEM?

CONTROLLED TEMPERATURE CABINET SYSTEM is a medical device that received FDA 510(k) clearance on 1998-05-07. The listed applicant is Smith. The 510(k) number is K973747.

When did CONTROLLED TEMPERATURE CABINET SYSTEM receive FDA 510(k) clearance?

CONTROLLED TEMPERATURE CABINET SYSTEM received FDA 510(k) clearance on 1998-05-07, under 510(k) number K973747.

Who is the listed applicant for CONTROLLED TEMPERATURE CABINET SYSTEM?

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

What is the FDA product code for CONTROLLED TEMPERATURE CABINET SYSTEM?

The FDA product code for CONTROLLED TEMPERATURE CABINET SYSTEM is LDQ.

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 Smith 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.

K973748TEMPO AND TEMP H20K972123PROTECTIVE RESTRAINT MODELS #302,440,750,850,AND905K971092QA-ESK970555IL0292 DP ECHOPORT

Related Devices (Code: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., Inc.K945374ACU-HALTEva-Health USA, 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.

↑