FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
TYPE INTERFACE 9271/1 INCUBATOR/WARMER
K Number: K912000
·
Decision Sep 21, 1992
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
84
Applicant Total
46
Review Days
516
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Basic Information
- Device Name
- TYPE INTERFACE 9271/1 INCUBATOR/WARMER
- K Number
- K912000
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5400
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- S & W Medico Teknik
- Date Received
- April 24, 1991
- Decision Date
- September 21, 1992
- Product Code
- FMZ
- 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 |
|---|---|---|---|
| FMZ | Incubator, Neonatal | FDA class 2 | General Hospital |
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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 |
| K912183 | TYPE 9050/NEO | Jun 23, 1992 | Substantially Equivalent |
| K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | May 5, 1992 | Substantially Equivalent |