Product code KLK
- Device name
- Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.2500
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003943 | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | 2001-05-04 |
| K991644 | MICROGAS 7650 TRANSCUTANEOUS MONITOR | Linde Medical Sensors AG | 1999-05-21 |
| K980287 | SIEMENS SC9000/SC9015 TCP02/C02 MODULE | Siemens Medical Solutions USA, Inc. | 1998-08-12 |
| K924709 | SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE | Air-Shields, Inc. | 1996-01-17 |
| K924679 | OXYCARE(TM) OXYGEN CONTROLLER/MONITOR | Air-Shields Vickers, Inc. | 1995-02-21 |
| K925910 | HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE | Hewlett-Packard Co. | 1993-07-29 |
| K893133 | HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX | Mennen Medical, Inc. | 1989-07-14 |
| K870805 | MODEL 840 TRANSCUTAN. OXYGEN/CARBON DIOX. MONITOR | Novametrix Medical Systems, Inc. | 1987-05-27 |
| K861861 | 515A NEO-TRAK NEONATAL MONITOR | Ge Medical Systems Information Technologies | 1986-07-10 |
| K860124 | HORIZON 2000 TRANSCUTANEOUS GAS MONITORING | Mennen Medical, Inc. | 1986-05-09 |
| K860951 | KONTRON CUTANEOUS PO2 MONITOR 820 | Kontron Instruments, Inc. | 1986-04-09 |
| K852959 | PO-510 TCPO2 MONITOR | Sumitomo Electric Industries, Inc. | 1985-11-29 |
| K851451 | STAT GAS MODULE | Vulcan Laboratories, Inc. | 1985-08-02 |
| K844253 | NOVAMETRIX 811 TRANSCO2M PORTABLE TRANSCUTANEOUS 2 | Novametrix Medical Systems, Inc. | 1985-01-10 |
| K844079 | NOVAMETRIX 860 PROTA. TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | 1984-11-30 |
| K842497 | SERVOMED OXYMONITO SMK 363 | Litton Datamedix | 1984-10-04 |
| K842374 | NOVAMETRIX 850 TRANSCUTANEOUS OXYGEN | Novametrix Medical Systems, Inc. | 1984-09-17 |
| K840993 | TRANSCUTANEOUS 800-OXYGEN MONITORS/801 | Novametrix Medical Systems, Inc. | 1984-04-24 |
| K840918 | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT | Biochem International, Inc. | 1984-04-17 |
| K840919 | DAYPAK SYS VII CATHETER CARE KIT | Creative Care Systems, Inc. | 1984-04-17 |
| K831319 | PATIENT MONITOR #404 | Analogic Corp. | 1984-03-22 |
| K834057 | IL 301 PORTABLE TRANSCUT. OXYGEN MONI | Instrumentation Laboratory CO | 1984-02-04 |
| K832652 | OXY MONITOR 5-RANGE DUAL-THERMISTOR | Litton Medical Electronics | 1983-12-22 |
| K830197 | TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS | Diamond Shamrock Corp. | 1983-11-29 |
| K831744 | TRANSCUTANEOUS OXYGEN MONITOR OPTION | Ge Medical Systems Information Technologies | 1983-07-19 |
| K831460 | AS 30/TCP MODULE | Narco Scientific | 1983-07-12 |
| K822328 | IL 301 TRANSCUTANEOUS OXYGEN MONITOR | Instrumentation Laboratory CO | 1982-09-07 |
| K821936 | CRITIKON OXYGEN MONITOR, MODEL 8030 | Critikon Company, LLC | 1982-08-16 |
| K813350 | NOVAMETRIX MODEL 807 TRANSCUT. MONITOR | Novametrix Medical Systems, Inc. | 1982-02-12 |
| K813347 | CRITIKON TRANSCUTANEOUS GAS MONITORS | Critikon Company, LLC | 1982-01-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07640121880315 | PSG-X | SenTec AG | 2018-11-12 |
| 07640121880681 | PSG Cable H | SenTec AG | 2018-11-12 |
| 07640121880674 | PSG Cable G | SenTec AG | 2018-11-12 |
| 07640121880667 | PSG Cable F | SenTec AG | 2018-11-12 |
| 07640121880650 | PSG Cable E | SenTec AG | 2018-11-12 |
| 07640121880643 | PSG Cable D | SenTec AG | 2018-11-12 |
| 07640121880636 | PSG Cable C | SenTec AG | 2018-11-12 |
| 07640121880629 | PSG Cable B | SenTec AG | 2018-11-12 |
| 07640121880612 | PSG Cable A | SenTec AG | 2018-11-12 |
| 05700699058669 | Electrolyte 54 | Radiometer Medical ApS | 2016-09-01 |
| 05700699056894 | TC contact liquid | Radiometer Medical ApS | 2016-09-01 |
| 05700699058683 | Membraning kit for tc sensor 54 | Radiometer Medical ApS | 2016-09-01 |
| 07640121880506 | Membrane Changer Inserts | SenTec AG | 2016-08-31 |
| 07640121880018 | Sentec Digital Monitor | SenTec AG | 2016-08-31 |
| 07640121880032 | Digital Sensor Adapter Cable, 150 cm | SenTec AG | 2016-08-31 |
| 07640121880049 | Ear Clip | SenTec AG | 2016-08-31 |
| 07640121880056 | Service gas | SenTec AG | 2016-08-31 |
| 07640121880070 | Contact Gel | SenTec AG | 2016-08-31 |
| 07640121880087 | Membrane Changer (reloadable) / single unit | SenTec AG | 2016-08-31 |
| 07640121880568 | Staysite Adhesive | SenTec AG | 2016-08-31 |
| 07640121880513 | V-Sign™ Sensor 2 | SenTec AG | 2016-08-31 |
| 07640121880094 | Standard Starter Set | SenTec AG | 2016-08-31 |
| 07640121880490 | Membrane Changer Set | SenTec AG | 2016-08-31 |
| 07640121880445 | Neonatal Starter Set (without Service Gas) | SenTec AG | 2016-08-31 |
| 07640121880438 | Neonatal Starter Set | SenTec AG | 2016-08-31 |
| 07640121880308 | Standard Starter Set (without Service Gas) | SenTec AG | 2016-08-31 |
| 07640121880230 | Multi-Site Attachment Ring for fragile/sensitive skin | SenTec AG | 2016-08-31 |
| 07640121880223 | Multi-Site Attachment Ring for mature/intact skin | SenTec AG | 2016-08-31 |
| 07640121880179 | Digital Sensor Adapter Cable, 750 cm | SenTec AG | 2016-08-31 |
| 07640121880162 | Digital Sensor Adapter Cable, 250 cm | SenTec AG | 2016-08-31 |