Gambro Ultrasonic Blood Level Detector Uld 10-200
FDA 510(k) K860076 · Gambro, Inc.
510(k) numberK860076
Submission
- Device name
- Gambro Ultrasonic Blood Level Detector Uld 10-200
- Applicant
- Gambro, Inc.
Lincolnshire, IL, US - Received
- January 8, 1986
- Decision date
- May 30, 1986
- 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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| 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 |
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| K873206 | Myocardial Temp. Sensor W/Type T ThermocoupleDTW · Traditional | Respiratory Support Products, Inc. | 09/30/1987SE |
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| K896758 | Gambro Bicarbonate Monitor BCM 10-3FKP · Traditional | 09/28/1990SE |
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| K902481 | Gambro Alwall GFS Plus 11, 16 & 20 Hollow FiberFJI · Traditional | 07/27/1990SE |
| K900918 | Gambro Lundia IC-6H Parallel Plate DialyzerKDI · Traditional | 07/16/1990SE |
| K892523 | Gambro Alwall GFS 11,12,PLUS 12 Hollow Fiber DialyFJI · Traditional | 05/11/1989SE |
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Questions and answers
When was Gambro Ultrasonic Blood Level Detector Uld 10-200 cleared by the FDA?
Gambro Ultrasonic Blood Level Detector Uld 10-200 (K860076) received a 510(k) decision of Substantially Equivalent on May 30, 1986, 142 days after the submission was received.
What is the product code of K860076?
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.