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FDA 510(k)

MOTI APRON

K-Number: K810095 · 1981-02-12

ApplicantMoti Enterprises, Inc.
Decision Date1981-02-12
Product CodeKPY
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MOTI APRON is the device name listed in this FDA 510(k) record. The listed applicant is Moti Enterprises, Inc.. It received FDA 510(k) clearance on 1981-02-12 under 510(k) number K810095. The device is classified under product code KPY. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MOTI APRON?

MOTI APRON is a medical device that received FDA 510(k) clearance on 1981-02-12. The listed applicant is Moti Enterprises, Inc.. The 510(k) number is K810095.

When did MOTI APRON receive FDA 510(k) clearance?

MOTI APRON received FDA 510(k) clearance on 1981-02-12, under 510(k) number K810095.

Who is the listed applicant for MOTI APRON?

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

What is the FDA product code for MOTI APRON?

The FDA product code for MOTI APRON is KPY.

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 Moti Enterprises, 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.

K843437MEI MAMMOGRAPHY SYS MX-2049K802377MOTI PROTECTIVE X-RAY MASK

Related Devices (Code: KPY)

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.

K110900DISPOSABLE THYROID COLLARBloxr CorporationK962622INTRA-ORAL THERMOPLASTIC SHIELDMedtec, Inc.K954456THERMOPLASTIC SHIELDMedtec, Inc.K954146UTK-DTE AUTILARY SHIELDMallinckrodt MedicalK953610AUKULYTEAukland Medical Plastics, Inc.K9510042001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)Kenex , Ltd.

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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