Cliniflow II, #701, Electromagn. Bld. Sy
FDA 510(k) K820272 · Carolina Medical Electronics
510(k) numberK820272
Submission
- Device name
- Cliniflow II, #701, Electromagn. Bld. Sy
- Applicant
- Carolina Medical Electronics
Walker, MI, US - Received
- February 2, 1982
- Decision date
- March 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| K223843 | FloPatch FP120DPW · Traditional | Flosonics Medical | 05/03/2023SE |
| K222242 | FloPatch FP120DPW · Traditional | Flosonics Medical | 12/09/2022SE |
| K213974 | GEM FLOW COUPLER Monitor (GEM1020M-2)DPW · Special | Synovis Micro Companies Alliance, Inc. | 04/20/2022SE |
| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek ChargerDPW · Traditional | Remington Medical, Inc. | 01/27/2022SE |
More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914200 | Vascumap Medical Air PlethysmographDSB · Traditional | 11/07/1991SE |
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| K874684 | TC2-64B Transcranial DopplerIYO · Traditional | 04/25/1988SE |
| K864624 | Probe, Uptake, NuclearIZO · Traditional | 08/10/1987SE |
| K843891 | Dopscan Plus DS1060IYO · Traditional | 01/09/1985SE |
| K837329 | Sonacolor CD, Model 6300 Cardiac Doppler Ultrasound · Traditional | 06/07/1983SE |
| K810561 | Dopscan Model 1050DPW · Traditional | 04/10/1981SE |
| K801647 | Sonacolor 6100DXY · Traditional | 08/20/1980SE |
| K792540 | Sonacolor 6000DXK · Traditional | 01/17/1980SE |
| K772015 | Patient Heater System, Model PH112DWJ · Traditional | 11/15/1977SE |
Questions and answers
When was Cliniflow II, #701, Electromagn. Bld. Sy cleared by the FDA?
Cliniflow II, #701, Electromagn. Bld. Sy (K820272) received a 510(k) decision of Substantially Equivalent on March 12, 1982, 38 days after the submission was received.
What is the product code of K820272?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.