Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NITE-GUIDE

K-Number: K931615 · 1995-04-14

ApplicantORTHO-TAIN, Inc.
Decision Date1995-04-14
Product CodeKMY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NITE-GUIDE is the device name listed in this FDA 510(k) record. The listed applicant is ORTHO-TAIN, Inc.. It received FDA 510(k) clearance on 1995-04-14 under 510(k) number K931615. The device is classified under product code KMY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITE-GUIDE?

NITE-GUIDE is a medical device that received FDA 510(k) clearance on 1995-04-14. The listed applicant is ORTHO-TAIN, Inc.. The 510(k) number is K931615.

When did NITE-GUIDE receive FDA 510(k) clearance?

NITE-GUIDE received FDA 510(k) clearance on 1995-04-14, under 510(k) number K931615.

Who is the listed applicant for NITE-GUIDE?

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

What is the FDA product code for NITE-GUIDE?

The FDA product code for NITE-GUIDE is KMY.

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 ORTHO-TAIN, 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.

K980952SNORE-CURE ANTI-SNORING APPLIANCE

Related Devices (Code: KMY)

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.

K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.K924351GLENROE ELASTIBITE STIMULATORGlenroe TechnologiesK925064RELAX-O-GUARDAquatemp Service Co., Inc.K924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERAmerican Orthodontics

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.

↑