Transkinetics Infrared Multi-Lead Tele Syst 7100
FDA 510(k) K904748 · Transtracheal Systems
510(k) numberK904748
Submission
- Device name
- Transkinetics Infrared Multi-Lead Tele Syst 7100
- Applicant
- Transtracheal Systems
Canton, MA, US - Received
- October 19, 1990
- Decision date
- March 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2910
- Specialty
- Cardiovascular
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More from Cardioline S.P.A
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|---|---|---|
| K982943 | Transtracheal Demand Oxygen Controller Model DOC-3000NFB · Traditional | 07/12/1999SE |
| K981078 | Transtracheal Augmented Ventilation Oxygen Concentrator Model Number Ttav 1000CAW · Traditional | 07/23/1998SE |
| K981080 | Scoop 1BTO · Traditional | 06/17/1998SE |
| K962944 | Transtracheal Demand Oxygen Controller (DOC-2000)NFB · Traditional | 10/23/1996SE |
| K904749 | Transkinetics Rado Freq Multi-Lead Tele Syst 7200DRQ · Traditional | 03/01/1991SE |
| K902281 | Modified Scoop Transtracheal CathetersBTO · Traditional | 08/10/1990SE |
| K854252 | Transtracheal System-Scoop-Insertion Tray-CatheterBTO · Traditional | 02/03/1986SESD |
Questions and answers
When was Transkinetics Infrared Multi-Lead Tele Syst 7100 cleared by the FDA?
Transkinetics Infrared Multi-Lead Tele Syst 7100 (K904748) received a 510(k) decision of Substantially Equivalent on March 1, 1991, 133 days after the submission was received.
What is the product code of K904748?
The FDA product code is DRG – Transmitters And Receivers, Physiological Signal, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 870.2910.