FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PAIN CARE 4200
K Number: K020988
·
Decision Apr 4, 2002
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
87
Applicant Total
16
Review Days
8
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Basic Information
- Device Name
- PAIN CARE 4200
- K Number
- K020988
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Breg, Inc.
- Date Received
- March 27, 2002
- Decision Date
- April 4, 2002
- Product Code
- MEB
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| MEB | Pump, Infusion, Elastomeric | FDA class 2 | General Hospital |
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Other Clearances by Breg, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K183702 | Polar Care Wave | Mar 1, 2019 | Substantially Equivalent |
| K070402 | MODIFICATION TO POLAR CARE 500 | Mar 29, 2007 | Substantially Equivalent |
| K041714 | E-PAIN CARE | Oct 1, 2004 | Substantially Equivalent |
| K013928 | PAIN CARE 3200 | Dec 3, 2001 | Substantially Equivalent |
| K003611 | PAIN CARE MULTI-PORT CATHETER, MODEL 2000L | Dec 13, 2000 | Substantially Equivalent |
| K002073 | PAIN CARE 3000 | Sep 19, 2000 | Substantially Equivalent |
| K002321 | PAIN CARE 2000L | Aug 14, 2000 | Substantially Equivalent |
| K983454 | PAIN CARE 2000 | Dec 16, 1998 | Substantially Equivalent |
| K963596 | POLAR CARE 300 | Dec 4, 1996 | Substantially Equivalent |
| K961855 | POLAR CARE (MODEL 500/50000) | Aug 9, 1996 | Substantially Equivalent |