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)

BIOMA 5000

K-Number: K880036 · 1988-03-07

ApplicantE.B.S., Inc.
Decision Date1988-03-07
Product CodeDRG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIOMA 5000 is the device name listed in this FDA 510(k) record. The listed applicant is E.B.S., Inc.. It received FDA 510(k) clearance on 1988-03-07 under 510(k) number K880036. The device is classified under product code DRG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOMA 5000?

BIOMA 5000 is a medical device that received FDA 510(k) clearance on 1988-03-07. The listed applicant is E.B.S., Inc.. The 510(k) number is K880036.

When did BIOMA 5000 receive FDA 510(k) clearance?

BIOMA 5000 received FDA 510(k) clearance on 1988-03-07, under 510(k) number K880036.

Who is the listed applicant for BIOMA 5000?

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

What is the FDA product code for BIOMA 5000?

The FDA product code for BIOMA 5000 is DRG.

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 E.B.S., 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.

K872370BIOMA 3500K862808BIOMA 2000

Related Devices (Code: DRG)

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.

K261569UbiqVue™ 2AYe Cardiac System (UX2253)Lifesignals, Inc.K252984Perin Health System (PHD80060-2)Perin Health Devices, LLCK252440EasyTeleMed (2.0.2)Ingeniars S.R.L.K250259TeleRehab Aermos Cardiopulmonary RehabilitationThe ScottCare CorporationK243837iBSMIorbit Digital Technologies Private LimitedK242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, 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.

↑