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FDA 510(k)

ACCU-O-MATIC

K-Number: K841427 · 1985-03-05

ApplicantMyomed, Inc.
Decision Date1985-03-05
Product CodeGZJ
Advisory CommitteeNE
DecisionUnknown

Device Summary

ACCU-O-MATIC is the device name listed in this FDA 510(k) record. The listed applicant is Myomed, Inc.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K841427. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ACCU-O-MATIC?

ACCU-O-MATIC is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Myomed, Inc.. The 510(k) number is K841427.

When did ACCU-O-MATIC receive FDA 510(k) clearance?

ACCU-O-MATIC received FDA 510(k) clearance on 1985-03-05, under 510(k) number K841427.

Who is the listed applicant for ACCU-O-MATIC?

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

What is the FDA product code for ACCU-O-MATIC?

The FDA product code for ACCU-O-MATIC is GZJ.

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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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