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FDA 510(k)

J4 MYO-MONITOR

K-Number: K842223 · 1984-11-19

ApplicantMyo-Tronics Research, Inc.
Decision Date1984-11-19
Product CodeNUW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

J4 MYO-MONITOR 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 1984-11-19 under 510(k) number K842223. The device is classified under product code NUW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J4 MYO-MONITOR?

J4 MYO-MONITOR is a medical device that received FDA 510(k) clearance on 1984-11-19. The listed applicant is Myo-Tronics Research, Inc.. The 510(k) number is K842223.

When did J4 MYO-MONITOR receive FDA 510(k) clearance?

J4 MYO-MONITOR received FDA 510(k) clearance on 1984-11-19, under 510(k) number K842223.

Who is the listed applicant for J4 MYO-MONITOR?

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 J4 MYO-MONITOR?

The FDA product code for J4 MYO-MONITOR is NUW.

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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 40K833132MUCOSAL ADJUSTMENT PASTE LIQUID SPRAYK831364TESTCORP RAK830034MODEL EM-2 BIOELECTRIC PROCESSORK813533ELECTRIC MUSCLE STIMULATORK810528MODEL EM-IR

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Related Devices (Code: NUW)

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.

K243290BTL-785MJBTL Industries, Inc.K203525D functionIto Co., Ltd.K040400MYO-TRODE SG DISPOSABLE ELECTRODEMyotronics-Noromed, Inc.K031998MODEL J-5 MVO-MONITORMyotronics-Noromed, Inc.K901902ACUSOURCE 600 FOR USE WITH TMJ ELECTRODEMicrocurrent Research, Inc.K890143ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CONMicrocurrent Research, Inc.

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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