FDA 510(k)

CARDIOVIT FT-1

K-Number: K170182 · 2017-07-19

Decision Date2017-07-19

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIOVIT FT-1 is the device name listed in this FDA 510(k) record. The listed applicant is Schiller AG. It received FDA 510(k) clearance on 2017-07-19 under 510(k) number K170182. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVIT FT-1?

CARDIOVIT FT-1 is a medical device that received FDA 510(k) clearance on 2017-07-19. The listed applicant is Schiller AG. The 510(k) number is K170182.

When did CARDIOVIT FT-1 receive FDA 510(k) clearance?

CARDIOVIT FT-1 received FDA 510(k) clearance on 2017-07-19, under 510(k) number K170182.

Who is the listed applicant for CARDIOVIT FT-1?

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

What is the FDA product code for CARDIOVIT FT-1?

The FDA product code for CARDIOVIT FT-1 is DPS.

Other records listing Schiller AG 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.

K253562medilogFD K221056ARGUS PB-3000 K183425CARDIOVIT AT-102 G2 K152043Diagnostic Station DS20

Related Devices (Code: DPS)

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)Withings K250569Cardiologs Holter PlatformPhilips France Commercial K243252ZBPro DiagnosticZbeats, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.