KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia Class II
FDA product code KLK covers "Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia", a Class II medical device regulated under 21 CFR 868.2500. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLK
- Device Class
- Class II
- Regulation Number
- 868.2500
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003943 | linde medical sensors | MICROGAS 7650 TRANSCUTANEOUS MONITOR | May 4, 2001 |
| K991644 | linde medical sensors | MICROGAS 7650 TRANSCUTANEOUS MONITOR | May 21, 1999 |
| K980287 | siemens medical solutions usa | SIEMENS SC9000/SC9015 TCP02/C02 MODULE | August 12, 1998 |
| K924709 | air-shields | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | January 17, 1996 |
| K924679 | air-shields vickers | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR | February 21, 1995 |
| K925910 | hewlett-packard | HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE | July 29, 1993 |
| K893133 | mennen medical | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX | July 14, 1989 |
| K870805 | novametrix medical systems | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR | May 27, 1987 |
| K861861 | ge medical systems information technologies | 515A NEO-TRAK NEONATAL MONITOR | July 10, 1986 |
| K860124 | mennen medical | HORIZON 2000 TRANSCUTANEOUS GAS MONITORING | May 9, 1986 |
| K860951 | kontron instruments | KONTRON CUTANEOUS PO2 MONITOR 820 | April 9, 1986 |
| K852959 | sumitomo electric industries | PO-510 TCPO2 MONITOR | November 29, 1985 |
| K851451 | vulcan laboratories | STAT GAS MODULE | August 2, 1985 |
| K844253 | novametrix medical systems | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 | January 10, 1985 |
| K844079 | novametrix medical systems | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN | November 30, 1984 |
| K842497 | litton datamedix | SERVOMED OXYMONITO SMK 363 | October 4, 1984 |
| K842374 | novametrix medical systems | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN | September 17, 1984 |
| K840993 | novametrix medical systems | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 | April 24, 1984 |
| K840918 | biochem international | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT | April 17, 1984 |
| K840919 | creative care systems | DAYPAK SYS VII CATHETER CARE KIT | April 17, 1984 |