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FDA 510(k)

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS

K-Number: K963620 · 1997-01-07

Applicant9th Wave, Inc.
Decision Date1997-01-07
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is 9th Wave, Inc.. It received FDA 510(k) clearance on 1997-01-07 under 510(k) number K963620. 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 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS?

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS is a medical device that received FDA 510(k) clearance on 1997-01-07. The listed applicant is 9th Wave, Inc.. The 510(k) number is K963620.

When did 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS receive FDA 510(k) clearance?

9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS received FDA 510(k) clearance on 1997-01-07, under 510(k) number K963620.

Who is the listed applicant for 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS?

The FDA 510(k) record lists 9th Wave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS?

The FDA product code for 9TH WAVE MODELS 500 & 550 LOW AIR LOSS SYSTEMS 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 9th Wave, 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.

K9636269TH WAVE MODELS 400 & 450 ALTERNATING PRESSURE MATTRESSK9636779TH WAVE MODEL 200 ALTERNATING PRESSURE PAD

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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