FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HBM HEMOGLOBINOMETER
K Number: K933836
·
Decision Mar 31, 1994
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
2
Applicant Total
4
Review Days
238
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Basic Information
- Device Name
- HBM HEMOGLOBINOMETER
- K Number
- K933836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Artel, Inc.
- Date Received
- August 5, 1993
- Decision Date
- March 31, 1994
- Product Code
- GIG
- 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 |
|---|---|---|---|
| GIG | Hemoglobinometer | FDA class 2 | Hematology |
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