FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
EQUASHIELD SYSTEM
K Number: K083152
·
Decision Feb 2, 2009
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
2
Review Days
101
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Basic Information
- Device Name
- EQUASHIELD SYSTEM
- K Number
- K083152
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Plastmed, Ltd.
- Date Received
- October 24, 2008
- Decision Date
- February 2, 2009
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Plastmed, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091389 | EQUALSHIELD LUER LOCK CONNECTOR PAIR | Oct 22, 2009 | Substantially Equivalent |