FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2
K Number: K921595
·
Decision Dec 24, 1992
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
29
Applicant Total
4
Review Days
265
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Basic Information
- Device Name
- Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2
- K Number
- K921595
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Haemotronic, Inc.
- Date Received
- April 3, 1992
- Decision Date
- December 24, 1992
- Product Code
- BRZ
- 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 |
|---|---|---|---|
| BRZ | Set, Blood Transfusion | FDA class 2 | General Hospital |
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