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)

BIOTEMP

K-Number: K896018 · 1990-02-09

ApplicantMedadvances, Inc.
Decision Date1990-02-09
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOTEMP is the device name listed in this FDA 510(k) record. The listed applicant is Medadvances, Inc.. It received FDA 510(k) clearance on 1990-02-09 under 510(k) number K896018. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOTEMP?

BIOTEMP is a medical device that received FDA 510(k) clearance on 1990-02-09. The listed applicant is Medadvances, Inc.. The 510(k) number is K896018.

When did BIOTEMP receive FDA 510(k) clearance?

BIOTEMP received FDA 510(k) clearance on 1990-02-09, under 510(k) number K896018.

Who is the listed applicant for BIOTEMP?

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

What is the FDA product code for BIOTEMP?

The FDA product code for BIOTEMP is LGZ.

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 Medadvances, 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.

K902650BODYHEATK904252HEATWAVE

Related Devices (Code: LGZ)

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.

K262532NORMOFLO™ Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)ICU MedicalK260988°M Warmer System with °M StationMequ A/SK252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.

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.

↑