510(k) K883485
K883485 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER PRESSURE MONITOR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 13, 1988. The device falls under product code FTY (Tape, Measuring, Rulers And Calipers), a Class I device regulated under 21 CFR 878.4800. Stryker Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1988
- Date Received
- August 16, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tape, Measuring, Rulers And Calipers
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type