Trip Tonometry Catheter, 18F
FDA 510(k) K980384 · Datex-Engstrom, Inc.
510(k) numberK980384
Submission
- Device name
- Trip Tonometry Catheter, 18F
- Applicant
- Datex-Engstrom, Inc.
Tewksbury, MA, US - Received
- February 2, 1998
- Decision date
- May 1, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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More from Southmedic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983366 | Trip Tonometry Catheter, 16FKNT · Traditional | 12/23/1998SE |
| K982091 | CS/3 Compact Airway Module, M-CovxMHX · Traditional | 12/22/1998SE |
| K981378 | Datex-Engstrom Light Monitor Models F-LM1, F-LMP1DRT · Traditional | 11/03/1998SE |
| K973985 | AS/3 Anaesthesia Delivery Unit (AS/3 Adu)BSZ · Traditional | 10/30/1998SE |
| K980362 | MRI Compatible Monitor and AccessoriesDPS · Traditional | 06/30/1998SE |
| K974792 | CS/3(TM) Monitors*DSI · Traditional | 06/02/1998SE |
| K974747 | CS/3 Arrhythmia WorkstationDSI · Traditional | 04/23/1998SE |
| K974101 | Datex-Engstrom NetworkMSX · Traditional | 02/06/1998SE |
| K964204 | Engstrom Hmef 1000CAH · Traditional | 11/13/1996SE |
Questions and answers
When was Trip Tonometry Catheter, 18F cleared by the FDA?
Trip Tonometry Catheter, 18F (K980384) received a 510(k) decision of Substantially Equivalent on May 1, 1998, 88 days after the submission was received.
What is the product code of K980384?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.