FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MOBILE MATIC AUTOMATIC DONOR SCALE
K Number: K810617
·
Decision Apr 7, 1981
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
7
Applicant Total
2
Review Days
29
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Basic Information
- Device Name
- MOBILE MATIC AUTOMATIC DONOR SCALE
- K Number
- K810617
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.9195
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Lifeline Instruments, Inc.
- Date Received
- March 9, 1981
- Decision Date
- April 7, 1981
- Product Code
- KSQ
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KSQ | Device, Blood Mixing And Blood Weighing | FDA class 1 | Hematology |
Similar 510(k) Clearances
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Other Clearances by Lifeline Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K760743 | DONORMATIC (BLOOD COLLECTION DEVICE) | Dec 6, 1976 | Substantially Equivalent |