PATHWAY ELECTROMYOGRAPH— 510(k) K973537
Substantially EquivalentThe Prometheus Group
FDA 510(k) clearance K973537 for PATHWAY ELECTROMYOGRAPH, Substantially Equivalent on 1997-12-17. Applicant: The Prometheus Group. Device class: 2.
Clearance details
- Applicant
- The Prometheus Group
- Product code
- Code HCC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5050
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Duxbury, MA, US
Recent devices under product code HCC
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- K001515 — PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
- K993976 — PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.