510(k) K801755
K801755 is an FDA 510(k) premarket notification submitted by Medical Measurements, Inc. for the device "MMI/GAELTEC CATHETER TIP PRESSURE". The FDA issued a decision of Substantially Equivalent on August 13, 1980. The device falls under product code GWM (Device, Monitoring, Intracranial Pressure), a Class II device regulated under 21 CFR 882.1620. Medical Measurements, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 1980
- Date Received
- July 28, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Monitoring, Intracranial Pressure
- Device Class
- Class II
- Regulation Number
- 882.1620
- Review Panel
- NE
- Submission Type