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)

DISPOSABLE DIAPHRAGM DOMES

K-Number: K813267 · 1981-12-14

ApplicantDio-Med Corp.
Decision Date1981-12-14
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE DIAPHRAGM DOMES is the device name listed in this FDA 510(k) record. The listed applicant is Dio-Med Corp.. It received FDA 510(k) clearance on 1981-12-14 under 510(k) number K813267. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE DIAPHRAGM DOMES?

DISPOSABLE DIAPHRAGM DOMES is a medical device that received FDA 510(k) clearance on 1981-12-14. The listed applicant is Dio-Med Corp.. The 510(k) number is K813267.

When did DISPOSABLE DIAPHRAGM DOMES receive FDA 510(k) clearance?

DISPOSABLE DIAPHRAGM DOMES received FDA 510(k) clearance on 1981-12-14, under 510(k) number K813267.

Who is the listed applicant for DISPOSABLE DIAPHRAGM DOMES?

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

What is the FDA product code for DISPOSABLE DIAPHRAGM DOMES?

The FDA product code for DISPOSABLE DIAPHRAGM DOMES is DRS.

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 Dio-Med 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.

K933525DIOMED 25 25W SURGICAL DIODE LASERK931776DIOMED 25 25W SURGICAL DIODE LASERK931212DIOMED 25 25W SURGICAL DIODE LASERK914519DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLICK914520DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICATK914521DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT

View all 7 devices →

Related Devices (Code: DRS)

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.

K254074TruPressProcerus EnterprisesK242909FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsEdwards Lifesciences, LLCK221782Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesMerit Medical Pte. , Ltd.K172458HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K163172HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer KitSmiths Medical Asd, Inc.K161408Compass Cast and MAPCenturion Medical Products Corporation

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.

↑