Mmi/Gaeltec Catheter Tip Pressure
FDA 510(k) K801755 · Medical Measurements, Inc.
510(k) numberK801755
Submission
- Device name
- Mmi/Gaeltec Catheter Tip Pressure
- Applicant
- Medical Measurements, Inc.
Nutley, NJ, US - Received
- July 28, 1980
- Decision date
- August 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K182073 | BcSs-PICNI-2000 SensorGWM · Traditional | Braincare Desenvolvimento E Inovacao Tecnologica… | 10/17/2019SE |
More from Braincare Desenvolvimento E Inovacao Tecnologica S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K921062 | Gaeltec MPR SeriesFFX · Traditional | 07/30/1992SE |
| K902097 | Model TR Rectal Suction Biopsy TubeFCK · Traditional | 07/27/1990SE |
| K863479 | Modified Ict/B Intracranial Press. Trans. EpiduralGWM · Traditional | 10/14/1986SE |
| K801757 | Mmi/Gaeltec Catheter Tip Press. TransduFES · Traditional | 08/27/1980SE |
| K801756 | Mmi/Gaeltec Catheter Tip TransducDXO · Traditional | 08/20/1980SE |
| K801880 | Mmi/Gaeltec Series 8T Diff. Press. TransBYR · Traditional | 08/14/1980SE |
| K801758 | Mmi/Gaeltec Catheter IntrauterineKXO · Traditional | 08/14/1980SE |
Questions and answers
When was Mmi/Gaeltec Catheter Tip Pressure cleared by the FDA?
Mmi/Gaeltec Catheter Tip Pressure (K801755) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 16 days after the submission was received.
What is the product code of K801755?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.