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FDA 510(k)

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL

K-Number: K103360 · 2010-12-17

ApplicantSiemens Corp.
Decision Date2010-12-17
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Corp.. It received FDA 510(k) clearance on 2010-12-17 under 510(k) number K103360. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL?

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL is a medical device that received FDA 510(k) clearance on 2010-12-17. The listed applicant is Siemens Corp.. The 510(k) number is K103360.

When did DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL receive FDA 510(k) clearance?

DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL received FDA 510(k) clearance on 2010-12-17, under 510(k) number K103360.

Who is the listed applicant for DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL?

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

What is the FDA product code for DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL?

The FDA product code for DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL is JIT.

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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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