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FDA 510(k)

AIRTEC2 LOW AIR LOSS THERAPY BED

K-Number: K970364 · 1997-11-17

ApplicantApex Metal, Inc.
Decision Date1997-11-17
Product CodeIOQ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

AIRTEC2 LOW AIR LOSS THERAPY BED is the device name listed in this FDA 510(k) record. The listed applicant is Apex Metal, Inc.. It received FDA 510(k) clearance on 1997-11-17 under 510(k) number K970364. 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 AIRTEC2 LOW AIR LOSS THERAPY BED?

AIRTEC2 LOW AIR LOSS THERAPY BED is a medical device that received FDA 510(k) clearance on 1997-11-17. The listed applicant is Apex Metal, Inc.. The 510(k) number is K970364.

When did AIRTEC2 LOW AIR LOSS THERAPY BED receive FDA 510(k) clearance?

AIRTEC2 LOW AIR LOSS THERAPY BED received FDA 510(k) clearance on 1997-11-17, under 510(k) number K970364.

Who is the listed applicant for AIRTEC2 LOW AIR LOSS THERAPY BED?

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

What is the FDA product code for AIRTEC2 LOW AIR LOSS THERAPY BED?

The FDA product code for AIRTEC2 LOW AIR LOSS THERAPY 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 Apex Metal, 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.

K970363HYDROTEC LOW AIR LOSS THERAPY BEDK970362CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM

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.K970636TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.K964873SILKAIR LOW AIRLOSS THERAPYHill-Rom, Inc.K970295FLEXICAIR EXLIPSE PLUSHill-Rom, 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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