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)

HUNTLEIGH DYNAMIC FLOTATION SYSTEM

K-Number: K890012 · 1989-03-29

ApplicantHuntleigh Technology, Inc.
Decision Date1989-03-29
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HUNTLEIGH DYNAMIC FLOTATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Technology, Inc.. It received FDA 510(k) clearance on 1989-03-29 under 510(k) number K890012. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HUNTLEIGH DYNAMIC FLOTATION SYSTEM?

HUNTLEIGH DYNAMIC FLOTATION SYSTEM is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Huntleigh Technology, Inc.. The 510(k) number is K890012.

When did HUNTLEIGH DYNAMIC FLOTATION SYSTEM receive FDA 510(k) clearance?

HUNTLEIGH DYNAMIC FLOTATION SYSTEM received FDA 510(k) clearance on 1989-03-29, under 510(k) number K890012.

Who is the listed applicant for HUNTLEIGH DYNAMIC FLOTATION SYSTEM?

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

What is the FDA product code for HUNTLEIGH DYNAMIC FLOTATION SYSTEM?

The FDA product code for HUNTLEIGH DYNAMIC FLOTATION SYSTEM is FNM.

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 Huntleigh Technology, 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.

K992733AKRON ATP9 TRACTION MACHINEK964699RHEO DOPPLEX II (RD 2)K924516OP3/VP4K910188FLOWPLUS AC330 PUMP GARMENTSK900882MULTI DOPPLEX, MD-1K900618HUNTLEIGH FETAL DOPPLER, FD-1 & DOPCORD, D140

View all 23 devices →

Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK972022ZAK-2000Cardio Systems, Inc.K974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, 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.

↑