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)

MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.

K-Number: K801138 · 1980-07-14

ApplicantGics Pharmaceuticals
Decision Date1980-07-14
Product CodeDRS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. is the device name listed in this FDA 510(k) record. The listed applicant is Gics Pharmaceuticals. It received FDA 510(k) clearance on 1980-07-14 under 510(k) number K801138. 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 MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.?

MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. is a medical device that received FDA 510(k) clearance on 1980-07-14. The listed applicant is Gics Pharmaceuticals. The 510(k) number is K801138.

When did MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. receive FDA 510(k) clearance?

MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. received FDA 510(k) clearance on 1980-07-14, under 510(k) number K801138.

Who is the listed applicant for MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.?

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

What is the FDA product code for MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN.?

The FDA product code for MODEL P-380 PHYSIOLOGICAL PRESSURE TRAN. 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 Gics Pharmaceuticals 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.

K802890CPS-1000K801136D300 DOMEK800849TMS 1000 TEMP. MONITOR & PROBES

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.

↑