FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOGLOBINOMETER MODEL 720 B
K Number: K781361
·
Decision Sep 14, 1978
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
38
Applicant Total
22
Review Days
38
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Basic Information
- Device Name
- HEMOGLOBINOMETER MODEL 720 B
- K Number
- K781361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5620
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Innovative Medical Systems, Inc.
- Date Received
- August 7, 1978
- Decision Date
- September 14, 1978
- Product Code
- GKR
- 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 |
|---|---|---|---|
| GKR | System, Hemoglobin, Automated | FDA class 2 | Hematology |
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