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FDA 510(k)

4C ABNORMAL LOW-HIGH (8 X 6 M1)

K-Number: K760682 · 1976-10-08

ApplicantCoulter Electronics, Inc.
Decision Date1976-10-08
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

4C ABNORMAL LOW-HIGH (8 X 6 M1) is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1976-10-08 under 510(k) number K760682. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4C ABNORMAL LOW-HIGH (8 X 6 M1)?

4C ABNORMAL LOW-HIGH (8 X 6 M1) is a medical device that received FDA 510(k) clearance on 1976-10-08. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K760682.

When did 4C ABNORMAL LOW-HIGH (8 X 6 M1) receive FDA 510(k) clearance?

4C ABNORMAL LOW-HIGH (8 X 6 M1) received FDA 510(k) clearance on 1976-10-08, under 510(k) number K760682.

Who is the listed applicant for 4C ABNORMAL LOW-HIGH (8 X 6 M1)?

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

What is the FDA product code for 4C ABNORMAL LOW-HIGH (8 X 6 M1)?

The FDA product code for 4C ABNORMAL LOW-HIGH (8 X 6 M1) is JPK.

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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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