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 TRAIN'R

K-Number: K780660 · 1978-07-28

ApplicantNite Train-R Enterprises, Inc.
Decision Date1978-07-28
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NITE TRAIN'R is the device name listed in this FDA 510(k) record. The listed applicant is Nite Train-R Enterprises, Inc.. It received FDA 510(k) clearance on 1978-07-28 under 510(k) number K780660. The device is classified under product code KPN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NITE TRAIN'R?

NITE TRAIN'R is a medical device that received FDA 510(k) clearance on 1978-07-28. The listed applicant is Nite Train-R Enterprises, Inc.. The 510(k) number is K780660.

When did NITE TRAIN'R receive FDA 510(k) clearance?

NITE TRAIN'R received FDA 510(k) clearance on 1978-07-28, under 510(k) number K780660.

Who is the listed applicant for NITE TRAIN'R?

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

What is the FDA product code for NITE TRAIN'R?

The FDA product code for NITE TRAIN'R is KPN.

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 Nite Train-R 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.

K872522BED ALERT

Related Devices (Code: KPN)

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.

K130951SIMSimavita Pty LimitedK971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5Humed, Inc.K971855POTTY PAL AND FOREVER-DRYDigital Applications, Inc.K962770UROSURGE ACUTRAINERPrinceton Regulatory Assoc.K962416DRYTIME FOR BLADDER CONTROL SILENTBio-Systems ResearchK955338DRYTIME FOR POTTY TRAININGHealth Sense Intl., 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.

↑