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)

ORION CENTRAL LINE DRESSING CHANGE TRAY

K-Number: K941542 · 1994-05-23

ApplicantRegulatory & Marketing Services, Inc.
Decision Date1994-05-23
Product CodeFRG
Advisory CommitteeHO
DecisionUnknown

Device Summary

ORION CENTRAL LINE DRESSING CHANGE TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Regulatory & Marketing Services, Inc.. It received FDA 510(k) clearance on 1994-05-23 under 510(k) number K941542. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ORION CENTRAL LINE DRESSING CHANGE TRAY?

ORION CENTRAL LINE DRESSING CHANGE TRAY is a medical device that received FDA 510(k) clearance on 1994-05-23. The listed applicant is Regulatory & Marketing Services, Inc.. The 510(k) number is K941542.

When did ORION CENTRAL LINE DRESSING CHANGE TRAY receive FDA 510(k) clearance?

ORION CENTRAL LINE DRESSING CHANGE TRAY received FDA 510(k) clearance on 1994-05-23, under 510(k) number K941542.

Who is the listed applicant for ORION CENTRAL LINE DRESSING CHANGE TRAY?

The FDA 510(k) record lists Regulatory & Marketing Services, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORION CENTRAL LINE DRESSING CHANGE TRAY?

The FDA product code for ORION CENTRAL LINE DRESSING CHANGE TRAY is FRG.

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 Regulatory & Marketing Services, 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.

K101721WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULAK944673MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBEK954752PEDIATRIC EUROPHYLIC FOLEY CATHETERK941342PAIN DOCK941543DIAL MEDICAL KITK944379ORION'S FOLEY CATHETERIZATION KIT WITH CATHETER AND BAG

View all 22 devices →

Related Devices (Code: FRG)

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.

K261897HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* HEAVY-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* STANDARD-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD* H300W Sterilization Wrap with ASSURE-DRY* TechnologyO&M Halyard, Inc.K252823Dukal Crepe Paper Sterilization WrapDukal, LLCK253454HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap; HALYARD* SEQUENTIAL Sterilization Wrap; HALYARD* SMART-FOLD* Sterilization WrapO&M Halyard, Inc.K251347Sterilization Pouch/RollSterivic Medical Co., Ltd.K251177Self-Seal Sterilization Pouch and RollGuangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., 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.

↑