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FDA 510(k)

PATHWAY ELECTROMYOGRAPH

K-Number: K973537 · 1997-12-17

ApplicantThe Prometheus Group
Decision Date1997-12-17
Product CodeHCC
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PATHWAY ELECTROMYOGRAPH is the device name listed in this FDA 510(k) record. The listed applicant is The Prometheus Group. It received FDA 510(k) clearance on 1997-12-17 under 510(k) number K973537. 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 PATHWAY ELECTROMYOGRAPH?

PATHWAY ELECTROMYOGRAPH is a medical device that received FDA 510(k) clearance on 1997-12-17. The listed applicant is The Prometheus Group. The 510(k) number is K973537.

When did PATHWAY ELECTROMYOGRAPH receive FDA 510(k) clearance?

PATHWAY ELECTROMYOGRAPH received FDA 510(k) clearance on 1997-12-17, under 510(k) number K973537.

Who is the listed applicant for PATHWAY ELECTROMYOGRAPH?

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

What is the FDA product code for PATHWAY ELECTROMYOGRAPH?

The FDA product code for PATHWAY ELECTROMYOGRAPH is HCC.

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Other records listing The Prometheus Group 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.

K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundK030039PATHWAY STM-10 PELVIC FLOOR STIMULATORK023906PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEMK001515PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000K993976PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSORK974036PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE

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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

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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