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)

MODIFIED COATRON II AND COATRON JR.

K-Number: K900506 · 1990-03-12

ApplicantAstral Medical Systems
Decision Date1990-03-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFIED COATRON II AND COATRON JR. is the device name listed in this FDA 510(k) record. The listed applicant is Astral Medical Systems. It received FDA 510(k) clearance on 1990-03-12 under 510(k) number K900506. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED COATRON II AND COATRON JR.?

MODIFIED COATRON II AND COATRON JR. is a medical device that received FDA 510(k) clearance on 1990-03-12. The listed applicant is Astral Medical Systems. The 510(k) number is K900506.

When did MODIFIED COATRON II AND COATRON JR. receive FDA 510(k) clearance?

MODIFIED COATRON II AND COATRON JR. received FDA 510(k) clearance on 1990-03-12, under 510(k) number K900506.

Who is the listed applicant for MODIFIED COATRON II AND COATRON JR.?

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

What is the FDA product code for MODIFIED COATRON II AND COATRON JR.?

The FDA product code for MODIFIED COATRON II AND COATRON JR. is JPA.

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 Astral Medical Systems 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.

K851153COATRON F(SAME AS COATRON, BUT ALSO DOES FIBRINOGEK853734APOLLO DENSITOMETERK851154ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18

Related Devices (Code: JPA)

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.

K253658STA Satellite Max®Diagnostica Stago, Inc.K250965Automated Blood Coagulation Analyzer CN-Series (CN-6000)Sysmex America, Inc.K251024TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemoneticsK243858TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeHaemonetics CorporationK232018Citrated: K, KH, RTH, FFHHaemonetics CorporationK233790ACL TOP 970 CLInstrumentation Laboratory

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.

↑