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FDA 510(k)

MYO-TONE, INC. SYSTEM-80

K-Number: K822250 · 1982-09-22

ApplicantMyo-Tone, Inc.
Decision Date1982-09-22
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MYO-TONE, INC. SYSTEM-80 is the device name listed in this FDA 510(k) record. The listed applicant is Myo-Tone, Inc.. It received FDA 510(k) clearance on 1982-09-22 under 510(k) number K822250. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYO-TONE, INC. SYSTEM-80?

MYO-TONE, INC. SYSTEM-80 is a medical device that received FDA 510(k) clearance on 1982-09-22. The listed applicant is Myo-Tone, Inc.. The 510(k) number is K822250.

When did MYO-TONE, INC. SYSTEM-80 receive FDA 510(k) clearance?

MYO-TONE, INC. SYSTEM-80 received FDA 510(k) clearance on 1982-09-22, under 510(k) number K822250.

Who is the listed applicant for MYO-TONE, INC. SYSTEM-80?

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

What is the FDA product code for MYO-TONE, INC. SYSTEM-80?

The FDA product code for MYO-TONE, INC. SYSTEM-80 is IPF.

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Related Devices (Code: IPF)

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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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