FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
K Number: K960508
·
Decision Jan 16, 1997
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
11
Review Days
346
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Basic Information
- Device Name
- PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25
- K Number
- K960508
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- The Prometheus Group
- Date Received
- February 5, 1996
- Decision Date
- January 16, 1997
- Product Code
- HIR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIR | Perineometer | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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Other Clearances by The Prometheus Group
| K Number | Device Name | ||
|---|---|---|---|
| K160792 | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound | Apr 15, 2016 | Substantially Equivalent |
| K030039 | PATHWAY STM-10 PELVIC FLOOR STIMULATOR | May 23, 2003 | Substantially Equivalent |
| K023906 | PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM | Feb 19, 2003 | Substantially Equivalent |
| K001515 | PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000 | Jul 31, 2000 | Substantially Equivalent |
| K993976 | PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR | Feb 22, 2000 | Substantially Equivalent |
| K974036 | PATHWAY VAGINAL/RECTAL PERINEOMETER PROBE | Dec 22, 1997 | Substantially Equivalent |
| K973537 | PATHWAY ELECTROMYOGRAPH | Dec 17, 1997 | Substantially Equivalent |
| K960761 | PATHWAY ELECTROMYOGRAPH MODEL TR-10 & TR-20 | Aug 7, 1996 | Substantially Equivalent |
| K960762 | SYNERGY PLUS | Jun 13, 1996 | Substantially Equivalent |
| K897132 | PATHWAY II ELECTROMYOGRAPH | Apr 18, 1991 | Substantially Equivalent |