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FDA 510(k)

DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL

K-Number: K113373 · 2011-12-30

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2011-12-30
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-12-30 under 510(k) number K113373. 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 LOCI 9 CALIBRATOR- LOCI 9 CAL?

DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL is a medical device that received FDA 510(k) clearance on 2011-12-30. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K113373.

When did DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL receive FDA 510(k) clearance?

DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL received FDA 510(k) clearance on 2011-12-30, under 510(k) number K113373.

Who is the listed applicant for DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL?

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

What is the FDA product code for DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL?

The FDA product code for DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 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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