FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEFI 2
K Number: K851931
·
Decision Aug 5, 1985
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
165
Applicant Total
46
Review Days
95
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Basic Information
- Device Name
- DEFI 2
- K Number
- K851931
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- S & W Medico Teknik
- Date Received
- May 2, 1985
- Decision Date
- August 5, 1985
- Product Code
- LDD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | FDA class 2 | Cardiovascular |
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Other Clearances by S & W Medico Teknik
| K Number | Device Name | ||
|---|---|---|---|
| K940933 | 9267 SPO2 ATHENA MODULE | Nov 29, 1995 | Substantially Equivalent |
| K913013 | TCPO2 9260 MODULE - SYSTEM ATHENA | May 3, 1994 | Substantially Equivalent |
| K915633 | MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA | Jun 29, 1993 | Substantially Equivalent |
| K930134 | 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT | Apr 9, 1993 | Substantially Equivalent |
| K923418 | 9293/1 INTERFACE MODULE | Feb 23, 1993 | Substantially Equivalent |
| K911611 | SYSTEM ATHENA, MODIFICATION | Feb 5, 1993 | Substantially Equivalent |
| K922314 | VENTILATOR INTERFACE 9291/4 | Dec 17, 1992 | Substantially Equivalent |
| K912815 | NIBP 9225 COMBI | Oct 9, 1992 | Substantially Equivalent |
| K912000 | TYPE INTERFACE 9271/1 INCUBATOR/WARMER | Sep 21, 1992 | Substantially Equivalent |
| K912183 | TYPE 9050/NEO | Jun 23, 1992 | Substantially Equivalent |