FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
SYSTEM ATHENA, MODIFICATION
K Number: K911611
·
Decision Feb 5, 1993
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
46
Review Days
668
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SYSTEM ATHENA, MODIFICATION
- K Number
- K911611
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- S & W Medico Teknik
- Date Received
- April 9, 1991
- Decision Date
- February 5, 1993
- Product Code
- DRT
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DRT), ordered by most recent decision date.
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C300 System (C300)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (Model 2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
Sleepiz One+ (2.5)
FDA 510(k)
FDA Class 2
·Cardiovascular
The Circadia C200 System
FDA 510(k)
FDA Class 2
·Cardiovascular
Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| 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 |
| K912145 | SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA | May 5, 1992 | Substantially Equivalent |