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FDA 510(k)

HEMO-PULSE 2000

K-Number: K914142 · 1992-01-03

ApplicantChrono Dynamics, Ltd.
Decision Date1992-01-03
Product CodeIRP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

HEMO-PULSE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Chrono Dynamics, Ltd.. It received FDA 510(k) clearance on 1992-01-03 under 510(k) number K914142. The device is classified under product code IRP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMO-PULSE 2000?

HEMO-PULSE 2000 is a medical device that received FDA 510(k) clearance on 1992-01-03. The listed applicant is Chrono Dynamics, Ltd.. The 510(k) number is K914142.

When did HEMO-PULSE 2000 receive FDA 510(k) clearance?

HEMO-PULSE 2000 received FDA 510(k) clearance on 1992-01-03, under 510(k) number K914142.

Who is the listed applicant for HEMO-PULSE 2000?

The FDA 510(k) record lists Chrono Dynamics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMO-PULSE 2000?

The FDA product code for HEMO-PULSE 2000 is IRP.

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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.

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