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FDA 510(k)

CARDIOVIT AT-5C

K-Number: K941462 · 1995-05-19

ApplicantSchiller America, Inc.
Decision Date1995-05-19
Product CodeLOS
DecisionSubstantially Equivalent

Device Summary

CARDIOVIT AT-5C 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 1995-05-19 under 510(k) number K941462. The device is classified under product code LOS. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVIT AT-5C?

CARDIOVIT AT-5C is a medical device that received FDA 510(k) clearance on 1995-05-19. The listed applicant is Schiller America, Inc.. The 510(k) number is K941462.

When did CARDIOVIT AT-5C receive FDA 510(k) clearance?

CARDIOVIT AT-5C received FDA 510(k) clearance on 1995-05-19, under 510(k) number K941462.

Who is the listed applicant for CARDIOVIT AT-5C?

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 AT-5C?

The FDA product code for CARDIOVIT AT-5C 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.

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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-200K970879CARDIOVIT CS-200K953396CARDIOVIT AT-1C, AT-2CK954066MINISCOPE MS-3K946205CARDIOVIT AT-1, P-80

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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.

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