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FDA 510(k)

PROSIM 4, PROSIM 6, PROSIM 8

K-Number: K110429 · 2011-09-02

ApplicantFluke Biomedical
Decision Date2011-09-02
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROSIM 4, PROSIM 6, PROSIM 8 is the device name listed in this FDA 510(k) record. The listed applicant is Fluke Biomedical. It received FDA 510(k) clearance on 2011-09-02 under 510(k) number K110429. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSIM 4, PROSIM 6, PROSIM 8?

PROSIM 4, PROSIM 6, PROSIM 8 is a medical device that received FDA 510(k) clearance on 2011-09-02. The listed applicant is Fluke Biomedical. The 510(k) number is K110429.

When did PROSIM 4, PROSIM 6, PROSIM 8 receive FDA 510(k) clearance?

PROSIM 4, PROSIM 6, PROSIM 8 received FDA 510(k) clearance on 2011-09-02, under 510(k) number K110429.

Who is the listed applicant for PROSIM 4, PROSIM 6, PROSIM 8?

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

What is the FDA product code for PROSIM 4, PROSIM 6, PROSIM 8?

The FDA product code for PROSIM 4, PROSIM 6, PROSIM 8 is DRT.

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Other records listing Fluke Biomedical 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.

K121860ESA615K121722ESA620 ELECTRICAL SAFETY ANALYZERK103336MPS450 MULTIPARAMETER SIMULATORK083347IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADSK072114IMPULSE 6000D/7000DP

Related Devices (Code: DRT)

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Official Source

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