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FDA 510(k)

CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM

K-Number: K970362 · 1997-05-16

ApplicantApex Metal, Inc.
Decision Date1997-05-16
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM 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 1997-05-16 under 510(k) number K970362. 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 CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM?

CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 1997-05-16. The listed applicant is Apex Metal, Inc.. The 510(k) number is K970362.

When did CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM receive FDA 510(k) clearance?

CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM received FDA 510(k) clearance on 1997-05-16, under 510(k) number K970362.

Who is the listed applicant for CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM?

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 CARE TEC PORTABLE LOW AIR LOSS THERAPY SYSTEM?

The FDA product code for CARE TEC PORTABLE LOW AIR LOSS THERAPY 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 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 BEDK970364AIRTEC2 LOW AIR LOSS THERAPY BED

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.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/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.

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