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)

SENSI-CAL AMCO AEPA-1

K-Number: K935566 · 1994-03-29

ApplicantRadiometer America, Inc.
Decision Date1994-03-29
Product CodeLIE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SENSI-CAL AMCO AEPA-1 is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1994-03-29 under 510(k) number K935566. The device is classified under product code LIE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SENSI-CAL AMCO AEPA-1?

SENSI-CAL AMCO AEPA-1 is a medical device that received FDA 510(k) clearance on 1994-03-29. The listed applicant is Radiometer America, Inc.. The 510(k) number is K935566.

When did SENSI-CAL AMCO AEPA-1 receive FDA 510(k) clearance?

SENSI-CAL AMCO AEPA-1 received FDA 510(k) clearance on 1994-03-29, under 510(k) number K935566.

Who is the listed applicant for SENSI-CAL AMCO AEPA-1?

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

What is the FDA product code for SENSI-CAL AMCO AEPA-1?

The FDA product code for SENSI-CAL AMCO AEPA-1 is LIE.

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 Radiometer America, 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.

K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitK992859ABL700 SERIES ANALYZER WITH AUTOCHECK MODULEK991417ABL 735 ANALYZERK982928NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEMK980130ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEMK980135QUALICHECK5+ MODELS S7730, S7740, S7750, S7760

View all 50 devices →

Related Devices (Code: LIE)

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.

K221493MicroScan Prompt Inoculation System-DBeckman Coulter, Inc.K103456THE SENSITITRE AIMTrek Diagnostic SystemsK110331SENSITITRE AIM (TM)Trek Diagnostic Systems, Ltd.K911059TURBIDOMETRIC STANDARDScientific Device Laboratory, Inc.K890339DIFCO DIRECTOR INOCULATION SYSTEMDifco Laboratories, Inc.K820299PROMPT INOCULATION SYSTEM3M Company

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.

↑