FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IONOMETER E-HK AND ACCESSORIES
K Number: K880373
·
Decision Mar 17, 1988
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
14
Applicant Total
4
Review Days
50
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Basic Information
- Device Name
- IONOMETER E-HK AND ACCESSORIES
- K Number
- K880373
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5600
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Smash Ent., Inc.
- Date Received
- January 27, 1988
- Decision Date
- March 17, 1988
- Product Code
- GKF
- 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 |
|---|---|---|---|
| GKF | Instrument, Hematocrit, Automated | FDA class 2 | Hematology |
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