FDA 510(k)
FDA class 2
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
K Number: K023083
·
Decision Feb 28, 2003
Classifications
1
FEI Numbers
149
Registration Numbers
149
Same Product Code
847
Applicant Total
32
Review Days
164
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Basic Information
- Device Name
- SILBERG T.P.S., TISSUE PREPARATION SYSTEM, MODEL ME 800
- K Number
- K023083
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Mettler Electronics Corp.
- Date Received
- September 17, 2002
- Decision Date
- February 28, 2003
- Product Code
- FRN
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FRN | Pump, Infusion | FDA class 2 | General Hospital |
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| K053546 | SONICATOR 740, MODEL ME 740 | May 4, 2006 | Substantially Equivalent |
| K043586 | LASER SYS*STIM 540, MODEL ME 540 | May 6, 2005 | Substantially Equivalent |
| K042554 | AUTO THERM 390, MODEL ME 390 | Oct 8, 2004 | Substantially Equivalent |
| K031017 | SYS*STIM 208 AND 208A | May 30, 2003 | Substantially Equivalent |
| K022458 | AUTO*THERM 395, MODEL ME 395 | Sep 26, 2002 | Substantially Equivalent |
| K013192 | SONICATOR PLUS 930, MODEL ME 930 | Oct 17, 2001 | Substantially Equivalent |