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FDA 510(k)

CLINITRON AIR FLUIDIZED SUPPORT SYSTEM

K-Number: K813584 · 1982-01-12

ApplicantUhi Corp.
Decision Date1982-01-12
Product CodeINX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CLINITRON AIR FLUIDIZED SUPPORT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Uhi Corp.. It received FDA 510(k) clearance on 1982-01-12 under 510(k) number K813584. The device is classified under product code INX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLINITRON AIR FLUIDIZED SUPPORT SYSTEM?

CLINITRON AIR FLUIDIZED SUPPORT SYSTEM is a medical device that received FDA 510(k) clearance on 1982-01-12. The listed applicant is Uhi Corp.. The 510(k) number is K813584.

When did CLINITRON AIR FLUIDIZED SUPPORT SYSTEM receive FDA 510(k) clearance?

CLINITRON AIR FLUIDIZED SUPPORT SYSTEM received FDA 510(k) clearance on 1982-01-12, under 510(k) number K813584.

Who is the listed applicant for CLINITRON AIR FLUIDIZED SUPPORT SYSTEM?

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

What is the FDA product code for CLINITRON AIR FLUIDIZED SUPPORT SYSTEM?

The FDA product code for CLINITRON AIR FLUIDIZED SUPPORT SYSTEM is INX.

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 Uhi Corp. 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.

K843389CLINITRON AIR FLUIDIZED SUPPORT J-101UDK821835BARRIER BURN SHEET

Related Devices (Code: INX)

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.

K972176HOME CARE BEAD BEDKinetic Concepts, Inc.K964223CLINITRON RITE-HITEHill-Rom, Inc.K943385CLINITRON ELEXISSsi Medical Services, Inc.K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc.K931168X-20 AIR SUPPORT BEDAmerican Life Support Technology, Inc.K934689LOW AIR LOSS MATTRESS, MODIFICATIONCardio Systems, 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.

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