TCPO2 9260 Module - System Athena
FDA 510(k) K913013 · S & W Medico Teknik
510(k) numberK913013
Submission
- Device name
- TCPO2 9260 Module - System Athena
- Applicant
- S & W Medico Teknik
Denmark, DK - Received
- July 8, 1991
- Decision date
- May 3, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LKD – Monitor, Carbon-Dioxide, Cutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2480
- Specialty
- Anesthesiology
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More from Perimed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K940933 | 9267 SPO2 Athena ModuleDQA · Traditional | 11/29/1995SE |
| K915633 | Mod. Type 9230 Temp 1 and Temp 2 System AthenaFLL · Traditional | 06/29/1993SE |
| K930134 | 9055 Irca Option for System Athena 9050 NTDPS · Traditional | 04/09/1993SE |
| K923418 | 9293/1 Interface ModuleDQA · Traditional | 02/23/1993SE |
| K911611 | System Athena, ModificationDRT · Traditional | 02/05/1993SE |
| K922314 | Ventilator Interface 9291/4CBK · Traditional | 12/17/1992SE |
| K912815 | Nibp 9225 CombiDXN · Traditional | 10/09/1992SE |
| K912000 | Type Interface 9271/1 Incubator/WarmerFMZ · Traditional | 09/21/1992SE |
| K912183 | Type 9050/NEODPS · Traditional | 06/23/1992SE |
| K912145 | System Athena-Product Enhancements, AnesthesiaCCE · Traditional | 05/05/1992SE |
Questions and answers
When was TCPO2 9260 Module - System Athena cleared by the FDA?
TCPO2 9260 Module - System Athena (K913013) received a 510(k) decision of Substantially Equivalent on May 3, 1994, 1,030 days after the submission was received.
What is the product code of K913013?
The FDA product code is LKD – Monitor, Carbon-Dioxide, Cutaneous, a Class II (moderate risk) device regulated under 21 CFR 868.2480.