Myocardial Temp. Sensor W/Type T Thermocouple
FDA 510(k) K873206 · Respiratory Support Products, Inc.
510(k) numberK873206
Submission
- Device name
- Myocardial Temp. Sensor W/Type T Thermocouple
- Applicant
- Respiratory Support Products, Inc.
Costa Mesa, CA, US - Received
- August 14, 1987
- Decision date
- September 30, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTW – Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4340
- Specialty
- Cardiovascular
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|---|---|---|---|
| K150530 | Level Sensor, Level Sensor TapeDTW · Special | Medtronic, Inc. | 05/08/2015SE |
| K041558 | Stockertir Purge Control (Apc) SystemDTW · Special | Stockert Instrumente GmbH | 07/02/2004SE |
| K992857 | Levelsens - Flexible, Model 201110, Levelsens - Rigid, Model 201070DTW · Traditional | Rocky Mountain Research, Inc. | 11/10/1999SE |
| K955152 | Stockert S3 Ups, LVL CTRL Bubb. Det., Dual Press. Ctrl., Temp Mont., TimerDTW · Traditional | Stoeckert Instrumente | 02/22/1996SE |
| K910599 | Cardiopulmonary Bypass Level Sensing MonitorDTW · Traditional | Jtl Medical Corp. | 05/20/1993SE |
| K924354 | Stockert Caps Low Level Detect Ii/Bubble MonitorDTW · Traditional | Sorin Biomedica, Fiat, USA, Inc. | 02/18/1993SE |
| K915337 | Capiox Level AlarmDTW · Traditional | Terumo Medical Corp. | 02/21/1992SE |
| K900910 | Cobe Air Emboli Protection System (Aeps)DTW · Traditional | Cobe Laboratories, Inc. | 05/22/1990SE |
| K900815 | Sarns 9000 Perfusion System W/Alert Only LevelDTW · Traditional | 3M Company | 05/09/1990SE |
| K860076 | Gambro Ultrasonic Blood Level Detector Uld 10-200DTW · Traditional | Gambro, Inc. | 05/30/1986SE |
More from Gambro, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983862 | Cloud 1 Humidification SystemBTT · Traditional | 05/24/1999SE |
| K921190 | Adap-Temp Temperature Sensor AdapterFLL · Traditional | 03/09/1993SE |
| K920469 | Myocardinal Temperature Sensor with Type 400 SerieFLL · Traditional | 09/11/1992SE |
| K921510 | Gas Sampling Kit ModificationBZO · Traditional | 06/11/1992SE |
| K913082 | Bi-Temp Temperature Monitor,Model TM-300DFLL · Traditional | 12/11/1991SE |
| K913083 | Bi-Temp Temperature Monitor TM-201DFLL · Traditional | 10/17/1991SE |
| K912280 | Bi-Temp Temperature Monitor, Model TM-400DFLL · Traditional | 10/17/1991SE |
| K903816 | Urine Meter Foley Tray with Temperature SensorEZK · Traditional | 10/31/1990SEKD |
| K874694 | Adap-Temp, Model: AT-100FLL · Traditional | 03/01/1988SE |
| K873472 | Membrane HumidifierBTT · Traditional | 01/19/1988SE |
Questions and answers
When was Myocardial Temp. Sensor W/Type T Thermocouple cleared by the FDA?
Myocardial Temp. Sensor W/Type T Thermocouple (K873206) received a 510(k) decision of Substantially Equivalent on September 30, 1987, 47 days after the submission was received.
What is the product code of K873206?
The FDA product code is DTW – Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4340.