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)

MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85

K-Number: K884436 · 1988-12-02

ApplicantHarris Mfg. Co.
Decision Date1988-12-02
Product CodeKSE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 is the device name listed in this FDA 510(k) record. The listed applicant is Harris Mfg. Co.. It received FDA 510(k) clearance on 1988-12-02 under 510(k) number K884436. The device is classified under product code KSE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85?

MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 is a medical device that received FDA 510(k) clearance on 1988-12-02. The listed applicant is Harris Mfg. Co.. The 510(k) number is K884436.

When did MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 receive FDA 510(k) clearance?

MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 received FDA 510(k) clearance on 1988-12-02, under 510(k) number K884436.

Who is the listed applicant for MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85?

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

What is the FDA product code for MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85?

The FDA product code for MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85 is KSE.

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 Harris Mfg. Co. 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.

K921906HARRIS MODEL 2000

Related Devices (Code: KSE)

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.

K813327SEPCOR TEMPERATURE MONITORSeparation Science Corp.K802319HEMOTEMP TMMarion Laboratories, Inc.K800667MONITEMP BLOOD PACK TEMP. MONITORLiquid Crystal Products, 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.

↑