FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COAGULATOR
K Number: K852492
·
Decision Aug 13, 1985
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
13
Applicant Total
5
Review Days
62
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Basic Information
- Device Name
- COAGULATOR
- K Number
- K852492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Med USA
- Date Received
- June 12, 1985
- Decision Date
- August 13, 1985
- Product Code
- KQG
- 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 |
|---|---|---|---|
| KQG | Instrument, Coagulation | FDA class 2 | Hematology |
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Other Clearances by Med USA
| K Number | Device Name | ||
|---|---|---|---|
| K896766 | TD-28 DISPOSABLE ELECTRODE | Mar 14, 1990 | Substantially Equivalent |
| K862047 | COAGULATOR (8 CHANNEL) | Sep 29, 1986 | Substantially Equivalent |
| K850711 | INHALATION THERAPY NEBULIZER DEVICE | Jun 5, 1985 | Substantially Equivalent |
| K841803 | A1 SYSTEME 8201/2 | Feb 25, 1985 | Substantially Equivalent |