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FDA 510(k)

CAL-COUNT

K-Number: K801868 · 1980-08-27

ApplicantBayshore Systems Corp.
Decision Date1980-08-27
Product CodeISD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CAL-COUNT is the device name listed in this FDA 510(k) record. The listed applicant is Bayshore Systems Corp.. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801868. The device is classified under product code ISD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAL-COUNT?

CAL-COUNT is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Bayshore Systems Corp.. The 510(k) number is K801868.

When did CAL-COUNT receive FDA 510(k) clearance?

CAL-COUNT received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801868.

Who is the listed applicant for CAL-COUNT?

The FDA 510(k) record lists Bayshore Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAL-COUNT?

The FDA product code for CAL-COUNT is ISD.

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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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