FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REFLEX TREATMENT SYSTEM
K Number: K994079
·
Decision Mar 1, 2000
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
64
Applicant Total
8
Review Days
90
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Basic Information
- Device Name
- REFLEX TREATMENT SYSTEM
- K Number
- K994079
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.1425
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deschutes Medical Products, Inc.
- Date Received
- December 2, 1999
- Decision Date
- March 1, 2000
- 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 Deschutes Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002329 | PELVX GELLHORN VAGINAL PESSARY 603-608 | Sep 18, 2000 | Substantially Equivalent |
| K990593 | PELVX INCONTINENCE DISH, MODEL 301-306 | May 24, 1999 | Substantially Equivalent |
| K974116 | PELVX INCONTINENCE RING | Apr 27, 1998 | Substantially Equivalent |
| K974117 | PELVX DONUT, PELVX CUBE | Apr 27, 1998 | Substantially Equivalent |
| K974115 | PELVX RING, PELVX RING WITH SUPPORT | Apr 27, 1998 | Substantially Equivalent |
| K934552 | PERIPUMP | Aug 9, 1995 | Substantially Equivalent |
| K951569 | SURGACTIVATOR | Jun 6, 1995 | Substantially Equivalent |