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FDA 510(k)

STONY BROOK MODEL EECP-MC1

K-Number: K882401 · 1989-03-03

ApplicantStony Brook Trading and Development Corp.
Decision Date1989-03-03
Product CodeDRN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STONY BROOK MODEL EECP-MC1 is the device name listed in this FDA 510(k) record. The listed applicant is Stony Brook Trading and Development Corp.. It received FDA 510(k) clearance on 1989-03-03 under 510(k) number K882401. The device is classified under product code DRN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STONY BROOK MODEL EECP-MC1?

STONY BROOK MODEL EECP-MC1 is a medical device that received FDA 510(k) clearance on 1989-03-03. The listed applicant is Stony Brook Trading and Development Corp.. The 510(k) number is K882401.

When did STONY BROOK MODEL EECP-MC1 receive FDA 510(k) clearance?

STONY BROOK MODEL EECP-MC1 received FDA 510(k) clearance on 1989-03-03, under 510(k) number K882401.

Who is the listed applicant for STONY BROOK MODEL EECP-MC1?

The FDA 510(k) record lists Stony Brook Trading and Development Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STONY BROOK MODEL EECP-MC1?

The FDA product code for STONY BROOK MODEL EECP-MC1 is DRN.

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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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