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FDA 510(k)

PHYSIOTECH 4000 OR NORODYN 8000

K-Number: K922270 · 1994-09-02

ApplicantMyo-Tronics, Inc.
Decision Date1994-09-02
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PHYSIOTECH 4000 OR NORODYN 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Myo-Tronics, Inc.. It received FDA 510(k) clearance on 1994-09-02 under 510(k) number K922270. The device is classified under product code HCC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHYSIOTECH 4000 OR NORODYN 8000?

PHYSIOTECH 4000 OR NORODYN 8000 is a medical device that received FDA 510(k) clearance on 1994-09-02. The listed applicant is Myo-Tronics, Inc.. The 510(k) number is K922270.

When did PHYSIOTECH 4000 OR NORODYN 8000 receive FDA 510(k) clearance?

PHYSIOTECH 4000 OR NORODYN 8000 received FDA 510(k) clearance on 1994-09-02, under 510(k) number K922270.

Who is the listed applicant for PHYSIOTECH 4000 OR NORODYN 8000?

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

What is the FDA product code for PHYSIOTECH 4000 OR NORODYN 8000?

The FDA product code for PHYSIOTECH 4000 OR NORODYN 8000 is HCC.

Related Clinical Trials

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Other records listing Myo-Tronics, 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.

K970116ESG-1 ELECTROSONOGRAM (ESG-1)K944134K6-1 DIAGNOSTIC SYSTEM VERSION 3.1K922456K6-I DIAGNOSTIC SYSTEMK921919MS-100 MYO-SCANNER OR MS-100 EMG SCANNERK905449ELECTROSONOGRAM ESG-1

Related Devices (Code: HCC)

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.

K233580A Breathing System (ABS)Deepwell Dtx, Inc.K222101PrismGraymatters Health , Ltd.K180173FreespiraPalo Alto Health Sciences, Inc.K163448GrindCare SystemSunstar Suisse S.A.K131586CANARY BREATHING SYSTEMPalo Alto Health Sciences, Inc.K122879EEGER4 MODEL 4.3Eeg Software, LLC

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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