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FDA 510(k)

HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER

K-Number: K861505 · 1987-04-10

ApplicantAmerican Medical Equipment, Inc.
Decision Date1987-04-10
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Equipment, Inc.. It received FDA 510(k) clearance on 1987-04-10 under 510(k) number K861505. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER?

HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER is a medical device that received FDA 510(k) clearance on 1987-04-10. The listed applicant is American Medical Equipment, Inc.. The 510(k) number is K861505.

When did HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER receive FDA 510(k) clearance?

HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER received FDA 510(k) clearance on 1987-04-10, under 510(k) number K861505.

Who is the listed applicant for HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER?

The FDA 510(k) record lists American Medical Equipment, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER?

The FDA product code for HIPEC ANALYZER - HA 100 HI-PRO MULTI-ECG ANALYZER is DXG.

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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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