Event Marker & a Second Pressure Trend Output
FDA 510(k) K883518 · Metatech Corp.
510(k) numberK883518
Submission
- Device name
- Event Marker & a Second Pressure Trend Output
- Applicant
- Metatech Corp.
Wheeling, IL, US - Received
- August 16, 1988
- Decision date
- September 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Event Marker & a Second Pressure Trend Output cleared by the FDA?
Event Marker & a Second Pressure Trend Output (K883518) received a 510(k) decision of Substantially Equivalent on September 22, 1988, 37 days after the submission was received.
What is the product code of K883518?
The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.