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FDA 510(k)

MODIFICATION TO SYNCHRON CONTROL

K-Number: K013235 · 2001-10-16

ApplicantBeckman Coulter, Inc.
Decision Date2001-10-16
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SYNCHRON CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2001-10-16 under 510(k) number K013235. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO SYNCHRON CONTROL?

MODIFICATION TO SYNCHRON CONTROL is a medical device that received FDA 510(k) clearance on 2001-10-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K013235.

When did MODIFICATION TO SYNCHRON CONTROL receive FDA 510(k) clearance?

MODIFICATION TO SYNCHRON CONTROL received FDA 510(k) clearance on 2001-10-16, under 510(k) number K013235.

Who is the listed applicant for MODIFICATION TO SYNCHRON CONTROL?

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

What is the FDA product code for MODIFICATION TO SYNCHRON CONTROL?

The FDA product code for MODIFICATION TO SYNCHRON CONTROL is JJY.

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Related Devices (Code: JJY)

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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.

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