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)

BED SENTRY, MODEL 50U

K-Number: K850538 · 1985-04-03

ApplicantMetatech Corp.
Decision Date1985-04-03
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BED SENTRY, MODEL 50U is the device name listed in this FDA 510(k) record. The listed applicant is Metatech Corp.. It received FDA 510(k) clearance on 1985-04-03 under 510(k) number K850538. 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 BED SENTRY, MODEL 50U?

BED SENTRY, MODEL 50U is a medical device that received FDA 510(k) clearance on 1985-04-03. The listed applicant is Metatech Corp.. The 510(k) number is K850538.

When did BED SENTRY, MODEL 50U receive FDA 510(k) clearance?

BED SENTRY, MODEL 50U received FDA 510(k) clearance on 1985-04-03, under 510(k) number K850538.

Who is the listed applicant for BED SENTRY, MODEL 50U?

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

What is the FDA product code for BED SENTRY, MODEL 50U?

The FDA product code for BED SENTRY, MODEL 50U 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 Metatech Corp. 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.

K924314MOBILE STANDING FRAMEK915370COPPER VAPOR LASER SYSTEMK903883VASCULASE(R) COPPER VAPOR LASER SYST, PIGMENT LESK890865HEXASCAN SCANNER HANDPIECEK883541METALASER VASCULASEK883881MODIFIED MODEL 2001 FIBER OPTICS CATHETER

View all 13 devices →

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.

↑