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)

MODIFIED REFLUX REDUCER

K-Number: K883818 · 1988-11-21

ApplicantPhysician Engineered Products, Inc.
Decision Date1988-11-21
Product CodeFMS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODIFIED REFLUX REDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Physician Engineered Products, Inc.. It received FDA 510(k) clearance on 1988-11-21 under 510(k) number K883818. The device is classified under product code FMS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED REFLUX REDUCER?

MODIFIED REFLUX REDUCER is a medical device that received FDA 510(k) clearance on 1988-11-21. The listed applicant is Physician Engineered Products, Inc.. The 510(k) number is K883818.

When did MODIFIED REFLUX REDUCER receive FDA 510(k) clearance?

MODIFIED REFLUX REDUCER received FDA 510(k) clearance on 1988-11-21, under 510(k) number K883818.

Who is the listed applicant for MODIFIED REFLUX REDUCER?

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

What is the FDA product code for MODIFIED REFLUX REDUCER?

The FDA product code for MODIFIED REFLUX REDUCER is FMS.

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 Physician Engineered Products, 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.

K110550BRIGHT EMBRACE MODEL SBL60K093618BILI-MIRROR MODEL BLM-1K974830ULTRA BILI LIGHTK882291RETROFIT BABY FACE SHIELD (RFS)K882278RESUSCITATION BAG CONTROLLER (RBC)K873700INSTITUTIONAL BILI LIGHT (IBL)

View all 8 devices →

Related Devices (Code: FMS)

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.

K970334NATURE'S CRADLEInfant Advantage, Inc.K963210VAIL 100 PEDIATRIC CRIBVail Products, Inc.K960747NATURE'S CRADLE MODEL C1500Infant Advantage, Inc.K960012STRYKER ADEL BASSINETStryker Corp.K951024NATURE'S CRADLEInfant Advantage, Inc.K950059MC INFANT CARE UNIE #PP30Janco Consulting Services

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.

↑