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FDA 510(k)

INFLATABLE POSITIONING CUSHIONS

K-Number: K973915 · 1997-11-10

ApplicantKci New Technologies, Inc.
Decision Date1997-11-10
Product CodeIZH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFLATABLE POSITIONING CUSHIONS is the device name listed in this FDA 510(k) record. The listed applicant is Kci New Technologies, Inc.. It received FDA 510(k) clearance on 1997-11-10 under 510(k) number K973915. The device is classified under product code IZH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFLATABLE POSITIONING CUSHIONS?

INFLATABLE POSITIONING CUSHIONS is a medical device that received FDA 510(k) clearance on 1997-11-10. The listed applicant is Kci New Technologies, Inc.. The 510(k) number is K973915.

When did INFLATABLE POSITIONING CUSHIONS receive FDA 510(k) clearance?

INFLATABLE POSITIONING CUSHIONS received FDA 510(k) clearance on 1997-11-10, under 510(k) number K973915.

Who is the listed applicant for INFLATABLE POSITIONING CUSHIONS?

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

What is the FDA product code for INFLATABLE POSITIONING CUSHIONS?

The FDA product code for INFLATABLE POSITIONING CUSHIONS is IZH.

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 Kci New Technologies, 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.

K981311COWBOY XVK980235REMOTE HAND CONTROL TO THE INFLATABLE POSITIONING CUSHION (A.K.A. IMAGEAIR)

Related Devices (Code: IZH)

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.

K203509SMART FINDERIms Giotto S.P.A.K202294Affirm Contrast BiopsyHologic, Inc.K191495Biopsy PositionerFujifilm CorporationK161575Affirm Lateral Arm Upright Biopsy AccessoryHologicK161920Comfort CoverPrecision Dynamics CorporationK153486Affirm Prone Biopsy SystemHologic, 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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