FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
K Number: K020538
·
Decision May 15, 2002
Classifications
1
FEI Numbers
99
Registration Numbers
99
Same Product Code
63
Applicant Total
38
Review Days
85
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Basic Information
- Device Name
- BOEHRINGER LABORATORIES PNEUMATIC AMBULATORY COMPRESSION SYSTEM 8200 SERIES
- K Number
- K020538
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5780
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Boehringer Laboratories
- Date Received
- February 19, 2002
- Decision Date
- May 15, 2002
- Product Code
- DWL
- 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 |
|---|---|---|---|
| DWL | Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | FDA class 2 | General Hospital |
Similar 510(k) Clearances
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BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY ANTI-EMBOLISM STOCKINGS 10-20 MMHG, BOSSONG HOS
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