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FDA 510(k)

SYSTEM 3000 FLUIDIZED AIR BED

K-Number: K890935 · 1989-03-15

ApplicantDermanetics Corp.
Decision Date1989-03-15
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SYSTEM 3000 FLUIDIZED AIR BED is the device name listed in this FDA 510(k) record. The listed applicant is Dermanetics Corp.. It received FDA 510(k) clearance on 1989-03-15 under 510(k) number K890935. The device is classified under product code IOQ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM 3000 FLUIDIZED AIR BED?

SYSTEM 3000 FLUIDIZED AIR BED is a medical device that received FDA 510(k) clearance on 1989-03-15. The listed applicant is Dermanetics Corp.. The 510(k) number is K890935.

When did SYSTEM 3000 FLUIDIZED AIR BED receive FDA 510(k) clearance?

SYSTEM 3000 FLUIDIZED AIR BED received FDA 510(k) clearance on 1989-03-15, under 510(k) number K890935.

Who is the listed applicant for SYSTEM 3000 FLUIDIZED AIR BED?

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

What is the FDA product code for SYSTEM 3000 FLUIDIZED AIR BED?

The FDA product code for SYSTEM 3000 FLUIDIZED AIR BED is IOQ.

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 Dermanetics 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.

K894723SYSTEM 2500 MEDICAL WATERBED

Related Devices (Code: IOQ)

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.

K122473TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2Hill-RomK973624NURSE'S AID PATIENT ROTATION SYSTEMAir Med Assist ProductsK970363HYDROTEC LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970364AIRTEC2 LOW AIR LOSS THERAPY BEDApex Metal, Inc.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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