FDA 510(k)

EXL ANEM CAL, MODEL RC640

K-Number: K093645 · 2010-03-05

Decision Date2010-03-05

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EXL ANEM CAL, MODEL RC640 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2010-03-05 under 510(k) number K093645. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXL ANEM CAL, MODEL RC640?

EXL ANEM CAL, MODEL RC640 is a medical device that received FDA 510(k) clearance on 2010-03-05. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K093645.

When did EXL ANEM CAL, MODEL RC640 receive FDA 510(k) clearance?

EXL ANEM CAL, MODEL RC640 received FDA 510(k) clearance on 2010-03-05, under 510(k) number K093645.

Who is the listed applicant for EXL ANEM CAL, MODEL RC640?

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

What is the FDA product code for EXL ANEM CAL, MODEL RC640?

The FDA product code for EXL ANEM CAL, MODEL RC640 is JIX.

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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.