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)

PMS-2 PRESSURE MONITOR SEPARATOR

K-Number: K820912 · 1982-05-18

ApplicantDelta Medical Industries
Decision Date1982-05-18
Product CodeDXS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PMS-2 PRESSURE MONITOR SEPARATOR is the device name listed in this FDA 510(k) record. The listed applicant is Delta Medical Industries. It received FDA 510(k) clearance on 1982-05-18 under 510(k) number K820912. The device is classified under product code DXS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PMS-2 PRESSURE MONITOR SEPARATOR?

PMS-2 PRESSURE MONITOR SEPARATOR is a medical device that received FDA 510(k) clearance on 1982-05-18. The listed applicant is Delta Medical Industries. The 510(k) number is K820912.

When did PMS-2 PRESSURE MONITOR SEPARATOR receive FDA 510(k) clearance?

PMS-2 PRESSURE MONITOR SEPARATOR received FDA 510(k) clearance on 1982-05-18, under 510(k) number K820912.

Who is the listed applicant for PMS-2 PRESSURE MONITOR SEPARATOR?

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

What is the FDA product code for PMS-2 PRESSURE MONITOR SEPARATOR?

The FDA product code for PMS-2 PRESSURE MONITOR SEPARATOR is DXS.

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 Delta Medical Industries 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.

K833884ISOTEC DISPOS. PRESSURE TRANSDUCERK840253ONE-WAY AIR VALVEK832470INFUSION PUMPK830389ACCU-RYNGE PUMP SP-250K831750PM-3K822761DELIVERY TUBE SET #2226

View all 27 devices →

Related Devices (Code: DXS)

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.

K113235PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONSMedtronic, Inc.K944764VTI DISPOSABLE PRESSURE DISPLAY SETVascular Technology IncorporatedK912045TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYSTLifestream Int'L, Inc.K900797STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XRShiley, Inc.K873802PRESSURE BARRIER KIT CAT. NO. PBK-3American Omni Medical, Inc.K862836STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULEShiley, 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.

↑