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FDA 510(k)

MODEL EM-IR

K-Number: K810528 · 1981-03-31

ApplicantMyo-Tronics Research, Inc.
Decision Date1981-03-31
Product CodeKZM
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MODEL EM-IR is the device name listed in this FDA 510(k) record. The listed applicant is Myo-Tronics Research, Inc.. It received FDA 510(k) clearance on 1981-03-31 under 510(k) number K810528. The device is classified under product code KZM. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL EM-IR?

MODEL EM-IR is a medical device that received FDA 510(k) clearance on 1981-03-31. The listed applicant is Myo-Tronics Research, Inc.. The 510(k) number is K810528.

When did MODEL EM-IR receive FDA 510(k) clearance?

MODEL EM-IR received FDA 510(k) clearance on 1981-03-31, under 510(k) number K810528.

Who is the listed applicant for MODEL EM-IR?

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

What is the FDA product code for MODEL EM-IR?

The FDA product code for MODEL EM-IR is KZM.

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Other records listing Myo-Tronics Research, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K842224BNS 40K842223J4 MYO-MONITORK833132MUCOSAL ADJUSTMENT PASTE LIQUID SPRAYK831364TESTCORP RAK830034MODEL EM-2 BIOELECTRIC PROCESSORK813533ELECTRIC MUSCLE STIMULATOR

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Related Devices (Code: KZM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161716TEETHAN 2.0Bts S.P.A.K130158M-SCANBio-Research Associates, Inc.K113677GRINDCARE MEASUREMedotech A/SK082927BIOEMG IIIBio-Research Associates, Inc.K043373DOLOTENS DENTAL TM 1Neuromuscular Technologies, Inc.K030869BITESTRIPS.L.P. , Ltd.

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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