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)

BIO FLOTE(R)

K-Number: K900131 · 1990-02-16

ApplicantBio Clinic Co.
Decision Date1990-02-16
Product CodeFNM
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIO FLOTE(R) is the device name listed in this FDA 510(k) record. The listed applicant is Bio Clinic Co.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K900131. The device is classified under product code FNM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO FLOTE(R)?

BIO FLOTE(R) is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Bio Clinic Co.. The 510(k) number is K900131.

When did BIO FLOTE(R) receive FDA 510(k) clearance?

BIO FLOTE(R) received FDA 510(k) clearance on 1990-02-16, under 510(k) number K900131.

Who is the listed applicant for BIO FLOTE(R)?

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

What is the FDA product code for BIO FLOTE(R)?

The FDA product code for BIO FLOTE(R) is FNM.

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 Bio Clinic Co. 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.

K930791AMERICAN POWER CONVERSIONS, BACK-UPS 600K932480PRISMK926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALEK921958ELISA TUBE TSH TESTK922140ORTHODERM CONVERTIBLE IIK921211NOW PREGNANCY TEST KIT

View all 14 devices →

Related Devices (Code: FNM)

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.

K973169PRESSURE GUARD SITE SELECT (A)Span-America Medical Systems, Inc.K972022ZAK-2000Cardio Systems, Inc.K974319MIGHTY AIRWheelchairs of KansasK974070PHYSIO/1000Physio Designs, Inc.K972549SIMPULSEKinetic Concepts, Inc.K970081SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEMCathay Consolidated, 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.

↑