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)

CARDIOVIT CS-200

K-Number: K970879 · 1997-06-25

ApplicantSchiller America, Inc.
Decision Date1997-06-25
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIOVIT CS-200 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller America, Inc.. It received FDA 510(k) clearance on 1997-06-25 under 510(k) number K970879. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVIT CS-200?

CARDIOVIT CS-200 is a medical device that received FDA 510(k) clearance on 1997-06-25. The listed applicant is Schiller America, Inc.. The 510(k) number is K970879.

When did CARDIOVIT CS-200 receive FDA 510(k) clearance?

CARDIOVIT CS-200 received FDA 510(k) clearance on 1997-06-25, under 510(k) number K970879.

Who is the listed applicant for CARDIOVIT CS-200?

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

What is the FDA product code for CARDIOVIT CS-200?

The FDA product code for CARDIOVIT CS-200 is LOS.

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 Schiller 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.

K973735MICROVIT MT-100K973751MT-200K953396CARDIOVIT AT-1C, AT-2CK954066MINISCOPE MS-3K941462CARDIOVIT AT-5CK946205CARDIOVIT AT-1, P-80

View all 10 devices →

Related Devices (Code: LOS)

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.

K090895EKG-PLUS II SOFTWAREBionet Co., Ltd.K083749CARDIOVIEW32 REVIEW MODULEQrs Diagnostic, LLCK073376PHILIPS ECG ALGORITHMPhilips Medical SystemsK023034CARDIOTOUCH-3000Bionet Company, Ltd.K011328CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPHBionet Company, Ltd.K993616CARDIO-CARD INTERPRETATION SYSTEM INasiff Assoc., 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.

↑