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)

COIL DIALYZER MODEL ALT 140

K-Number: K761358 · 1977-01-10

ApplicantBentley Laboratories, Inc.
Decision Date1977-01-10
Product CodeFHS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COIL DIALYZER MODEL ALT 140 is the device name listed in this FDA 510(k) record. The listed applicant is Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1977-01-10 under 510(k) number K761358. The device is classified under product code FHS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COIL DIALYZER MODEL ALT 140?

COIL DIALYZER MODEL ALT 140 is a medical device that received FDA 510(k) clearance on 1977-01-10. The listed applicant is Bentley Laboratories, Inc.. The 510(k) number is K761358.

When did COIL DIALYZER MODEL ALT 140 receive FDA 510(k) clearance?

COIL DIALYZER MODEL ALT 140 received FDA 510(k) clearance on 1977-01-10, under 510(k) number K761358.

Who is the listed applicant for COIL DIALYZER MODEL ALT 140?

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

What is the FDA product code for COIL DIALYZER MODEL ALT 140?

The FDA product code for COIL DIALYZER MODEL ALT 140 is FHS.

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 Bentley Laboratories, 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.

K931967HE-30 GOLDK913956BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30K913692VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)K903641QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000QK894826UNIVOX W/HOLDERS, MODELS UNIVOX-HL, HLB, HLFK874867CATR(TM)-H CARDIOTOMY HOLDER

View all 55 devices →

Related Devices (Code: FHS)

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.

K812811MICROCOIL 80 DIALYZERErika, Inc.K811974MICROCOIL 150 DIALYZERErika, Inc.K801634THE VITA 2 DISPOSABLE DIALYZERBellco Artifidial Organ Spec., Inc.K800723MICRO-COIL 100 COIL DIALYZERErika, Inc.K800174GAMBRO LUNDIA COIL DIALYZERGambro, Inc.K790223DIALYZER, CD-800 COILTravenol Laboratories, S.A.

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.

↑