FDA 510(k)

MICROCELL COUNTER MODEL CC-108

K-Number: K780224 · 1978-05-19

ApplicantToa Medical Electronics USA, Inc.

Decision Date1978-05-19

Product CodeGKL

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

MICROCELL COUNTER MODEL CC-108 is the device name listed in this FDA 510(k) record. The listed applicant is Toa Medical Electronics USA, Inc.. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780224. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICROCELL COUNTER MODEL CC-108?

MICROCELL COUNTER MODEL CC-108 is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Toa Medical Electronics USA, Inc.. The 510(k) number is K780224.

When did MICROCELL COUNTER MODEL CC-108 receive FDA 510(k) clearance?

MICROCELL COUNTER MODEL CC-108 received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780224.

Who is the listed applicant for MICROCELL COUNTER MODEL CC-108?

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

What is the FDA product code for MICROCELL COUNTER MODEL CC-108?

The FDA product code for MICROCELL COUNTER MODEL CC-108 is GKL.

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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.