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FDA 510(k)

KAPPLER PRO/VENT BOOT

K-Number: K932738 · 1994-03-29

ApplicantKappler, Inc.
Decision Date1994-03-29
Product CodeFXP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

KAPPLER PRO/VENT BOOT is the device name listed in this FDA 510(k) record. The listed applicant is Kappler, Inc.. It received FDA 510(k) clearance on 1994-03-29 under 510(k) number K932738. The device is classified under product code FXP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KAPPLER PRO/VENT BOOT?

KAPPLER PRO/VENT BOOT is a medical device that received FDA 510(k) clearance on 1994-03-29. The listed applicant is Kappler, Inc.. The 510(k) number is K932738.

When did KAPPLER PRO/VENT BOOT receive FDA 510(k) clearance?

KAPPLER PRO/VENT BOOT received FDA 510(k) clearance on 1994-03-29, under 510(k) number K932738.

Who is the listed applicant for KAPPLER PRO/VENT BOOT?

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

What is the FDA product code for KAPPLER PRO/VENT BOOT?

The FDA product code for KAPPLER PRO/VENT BOOT is FXP.

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 Kappler, 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.

K932694KAPPLER PRO/VENT PROCEDURE GOWN

Related Devices (Code: FXP)

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.

K971076PRIMED SHOE COVERS, PRIMED HEAD COVERSPrimeline Medical Products, Inc.K971191FAR-EAST SHOE COVERSFar East Science & Technology Development Co., Ltd.K970815CONVERTORS IMPERVIOUS SHOE COVERSAllegiance Healthcare Corp.K961342SHOE COVER, NON-STERILECopioumed Intl., Inc.K955835FLUID BARRIER BOOT KNEE & ANKLE-HIGHInstrument Makar, Inc.K952897NIOMED SHOE COVERSAmerasia Corp.

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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